Isolation Systems and its Effectiveness in Oral and Maxillofacial Surgery: A Systematic Review

ABSTRACT

Introduction:

The success of restoration processes depends on the efficient control of moisture and microorganisms. Dental restorative procedures frequently use rubber dams as an isolation technique. There is still room for evidence-based discussion over how rubber dam use affects the durability and caliber of dental restorations. In this review, the effects of rubber dam isolation vs alternative isolation techniques for dental restorative procedures are compared.

Materials and Procedures:

An extensive online search in the various databanks of the EMBASE, Medline, Pubmed, and Scopus was conducted. The keywords searched were “isolation, oral surgery, dental surgery, retractors, rubber dam, and methods of isolation.” The studies selected were longitudinal research design and randomized trials. To ascertain the risk of bias, meta-analysis was carried out. The outcome was measured as the successful restoration at the end of follow-up period representing the thorough isolation.

Results:

A total of 1342 people were involved in six studies from across the world that were carried out between 2010 and 2015. High bias risk existed in all the studies. Five investigations compared the rubber dam vs cotton rolls. Due to discrepancies in the data supplied, one study was omitted from the analysis. Three of the four trials that were still running showed restored survival rates with all having a follow-up of at least six months. The survival of the restored composite teeth for six months in rubber dam isolation with odds ratio of 2.29, 1.38, and 1.00 at the end of six months, one year and one and half year respectively. However, the evidence was very low and speculative. The isolation was seen effective in the primary teeth specifically for the proximal lesions. None of the included studies discussed side effects or provided information on the treatment’s upfront costs.

Conclusion:

The application of rubber dams in dental techniques may result in successful outcome compared to cotton rolls, according to some low-certainty evidence revealed in this research. Other times, the evidence is really ambiguous. It is necessary to conduct additional, high-quality studies investigating how rubber dam use affects various restorative procedures.

INTRODUCTION

Dental restoration procedures are used to fix tooth damage brought on by trauma or caries. Direct restorative dentistry procedures, also referred to as “fillings,” restore teeth by employing amalgam or resin composite materials. Indirect methods use the lab prepared restorations. Controlling moisture and microbes are likely the two most crucial variables for successful repairs. In addition to reducing the danger of infection or re-infection, it helps adhere the restorations. Secondary cavities or poor bonding could jeopardize the restoration’s success or durability.[1-5]

Cotton rolls in conjunction with saliva ejector aspiration are a typical technique for moisture control and isolation in restorative dentistry. This method is commonly used and inexpensive, but it has the drawback that the dentist must often swap wet cotton rolls out during the procedure to keep the operating region dry.

A rubber dam is an alternative technique for isolating the tooth receiving restorative therapy. Dr. Sanford C. Barnum introduced this technique to the dental profession. Since then, numerous researchers have enhanced its use, and it is now a popular, useful substitute for cotton balls. Non-latex forms are also available. This rubber dam helps in preventing the moisture from the tooth working area and prevents the entry of the pathogens in the area of operation. It also prevents the tissues from various insults, gives a better visibility, and also helps in preventing the aspiration of some of the dental operative materials. Results from some studies have shown its protective effect on the person, even when it comes to general health, by preventing ingestion or aspiration of tools, materials, or irritants, as well as lowering patients’ exposure to mercury during the removal of amalgam restorations. Reduced microbiological load of aerosols generated during dental treatment also lowers the risk of cross-infection in the dental office. Many governments throughout the world have advised rubber dam therapy as standard medical practice during the coronavirus disease (COVID-19) epidemic.[6-10]

However, there are both actual and perceived drawbacks to using rubber dams. Concerns about patient acceptability, application time, material and equipment costs, inadequate training, and annoyance are frequently mentioned. The widespread use of rubber dams may also be hindered by latex allergy, breakage tooth structure loss, chipping of near apical thin veneer borders, and harm to the mucosa during placement or removal of the rubber dam. A much increased aerosol level on dentists may also be a problem that requires care, notwithstanding its clinical value. In both medical and dental operations, it is usual practice to physically surround a treatment location to lessen contamination from moisture and microorganisms. Rubber dams may lessen a person’s exposure to possibly dangerous side effects of mercury consumption when used in conjunction with amalgam restorations.[11-17]

Dentistry currently uses cotton rolls and rubber dams to seal off the treatment area and keep moisture out. From the distinct perspectives of the patient and the dentist, both techniques have benefits and drawbacks. The routine use of rubber dams during dental procedures has been praised for their exceptional performance in aerosol isolation throughout the COVID-19 epidemic. According to a review, using rubber dams during endodontic procedures is crucial since doing so improves root canal treatment outcomes and reduces the danger of patients swallowing or aspirating materials and tools. Its consequences on the functionality of restorations in patients undergoing dental restorative treatment are still unknown. Previous studies have been carried to test the isolation effectiveness of the rubber dam. These experiments’ findings seem to be contradictory. Additionally, several newly developed alternative isolation techniques (such as the Isolite system and the “Teflon tape approach”) outperformed the “gold-standard” rubber barrier in terms of acceptability and operability. Therefore, it is still required to summarize and describe this supporting data. The current systemic review aims to evaluate the isolation by rubber dam versus other forms of isolation used for various dental surgical procedures including the restoration. The benefits and potential drawbacks of various isolation procedures would then be made clear to both dentists and their patients using this information.

MATERIAL AND METHODS

Study design

A thorough analysis of longitudinal cohort studies and randomized controlled trials that used the rubber dam as well as other isolation methods was done. Analysis was made on the basis of the PRISMA standards.

Search technique

The manual and electronic literature searches up to 2020 in the databanks of the EMBASE, MEDLINE, PUBMED, and SCOPUS was conducted. The search terms were “Isolation, rubber dam or oral dam or dental dam or latex dam or KoHerdam or Optra dam or Optradam Plus or Optidam or Flexidam or Hygenic Fiesta, Oral Surgery, Dental Surgery, Retractors, Rubber dam AND Methods of Isolation AND (cohort OR longitudinal OR randomized controlled trial OR RCT).”

Selection standard

Two reviewers independently read, evaluated, and screened articles. and the differences were resolved with discussion. Articles that did not meet the requirements for inclusion were excluded.

Selection and scrutinizing

Titles and abstracts of publications were independently evaluated for eligibility. Relevant articles were picked for full-text screening. The paper screening process and eligibility assessment were carried out independently by two authors. In the event of a disagreement among the authors, the judgment was decided by an independent third author. Titles were screened firstly followed by the abstracts. When the abstracts did not fulfil the criteria of selection, the studies were excluded. Figure 1 in accordance with PRISMA recommendations is shown for the selected studies.[18]

Figure 1.

Flowchart exhibiting the study selection

Obtaining data and evaluating its quality

Independently, two researchers evaluated search results, chose studies, and extracted data. For additional review, the full documents were retrieved. The following criteria were gathered to create a customized Microsoft Excel spreadsheet, and the succeeding information was acquired from the inclusion criteria: “the name of the author and the year it was published, study design, patient age, country, and outcome variables.”

Eligibility requirements

Strict eligibility standards served as the search’s guide to assure the inclusion of relevant studies, minimize heterogeneity, and boost the power of the findings. The following were listed as the inclusion criteria:

• Design: Prospective trials were included that were properly randomized.

• Subjects: Subjects of >10 sample size.

• Follow-up: The evaluation of the results after at least 24 weeks articles those are available in English or were translatable.

• Randomized controlled trials and longitudinal retrospective/prospective cohort study designs.

• A least follow-up time of six months.

The study was asked to be excluded from the evaluation if it met one of the following standards:

• A cross-sectional, case-series, or case-control study.

• Research on animals or groups known to have a systemic disease before follow-up.

• Conference proceedings, abstracts, reviews, or protocols.

Statistic evaluation

The information gathered was entered into an Excel spreadsheet and analyzed (Microsoft, Redmond, Washington, USA). The analysis was valued at 95% significance levels. The “Newcastle-Ottawa Scale (NOS) for Quality Assessment” was used to appraise the value of the studies. “Cochran test (Test Q)” and “inconsistency test” (I² < 50%) were used to assess study heterogeneity. Values above 75% (in both tests) were regarded to indicate significant heterogeneity, preventing the use of a fixed-effect analytic approach. The “standard deviation (SD)” number was utilized to construct the “confidence interval (CI)” because the “confidence interval (CI)” was not provided. In addition, linear regression was used. RRs were created using ORs and HRs to enhance the size of the study. Key confounders, including demographics and smoking, were adjusted for respective trials and pooled with the adjusted RRs for the meta-analysis. Severity and the demographics as well as the follow-up time were all noted for the groups.

RESULTS

Initially conducted in August 2012, additional searches were conducted in April 2015, October 2015, and August 2016. Four studies of the 781 identified trials were included in the original draft of this study, which was published in 2016. Six studies were finalized for the systemic review that were published between 2010 and 2015.[16-21]

Trial settings and design characteristics

Split-mouth trials were done in two studies[16,20] and in four parallel design were used.[17-19,21] In the United States,[16] Germany,[17] Brazil,[19,20] Kenya,[18] and China[21], the studies were carried out. One study was directed in a private dental office,[17] another in a hospital dental office,[21] two at dental school clinics,[16,20] and two in academic institutions.[18,19] One study calculated the sample size but did not specify the methodology.[18] The sample size calculation was not mentioned in the other five investigations.[16,17,19,20] Three researches indicated that they got money from the industry, while one study[21] did not specify the source of funding[17,18,20]; the other two claimed to have gotten finance from outside the industry [Table 1].[16,19]

Table 1.

Comparison of the study characteristics

Study	Country	Design	Sample size	Groups
Alhareky 2014[16]	United States	Split-mouth RCT	42	Rubber dam vs Isolite system
Ammann 2013[17]	Germany	Parallel-group RCT	72	Rubber dam vs cotton roll
Carvalho 2010[18]	Brazil	Parallel-group RCT	232	Rubber dam vs cotton roll
Kemoli 2010[19]	Kenya	Parallel-group RCT	804	Rubber dam vs cotton roll
Loguercio 2015[20]	Brazil	Split-mouth RCT	30	Rubber dam vs cotton roll
Ma 2012[21]	China	parallel-group RCT	162	Rubber dam vs cotton roll

Participants’ characteristics

An aggregate of 1342 were incorporated in the study. Kids below the age of 18 were included in the study of[16,17] Alhareky (2014) enrolled 42 kids between the ages of 7 and 16; all the kids involved underwent premolar or molar pit and fissure sealing.[16] Both Ma 2012 (162 participants, unclear age range)[21] and Loguercio 2015 (30 adults, mean age 45 years) evaluated patients getting resin composite restorations for “non-cancerous cervical lesions (NCCLs).”[20] Children receiving proximal primary “atraumatic restorative treatment (ART)” in primary molars were included in studies of Kemoli 2010[18] and Carvalho 2010.[19] Direct dental restoration procedures were administered to all the study subjects.

Interventional characteristics

Rubber dam was applied in all the six studies. Five of the included trials[17-21] used cotton rolls as a control group, while one study used the Isolite system.[16]

The outcome measures’ characteristics are as follows

The studies’ definitions of what constitutes “survival or failure of the restorations” varied. According to Carvalho 2010[19] and Kemoli 2010,[18] restoration survival was defined as the presence of restorations with general wear and marginal flaws that were both 0.5 mm deep or less at their deepest point. Failure was defined by Ma (2012)[21] as the absence of the restoration at the time of evaluation. According to the FDI criteria used for clinical evaluation, Loguercio (2015)[20] classified retained as “restoration retained, no fractures/cracks, small hairline crack, or two or more or bigger hairline cracks or chipping or both (without damaging the marginal integrity).” The four studies did not mention any negative incidents. The survival rate and negative consequences were not reported by Alhareky (2014)[16] or Ammann (2013).[17]

In addition, Loguercio (2015)[20] assessed the restorations’ performance in terms of their appearance, utility, and biological characteristics. Two researches (Alhareky 2014[16]; Loguercio 2015[20]) evaluated the degree of participants’ acceptance or satisfaction with rubber dam isolation compared to cotton rolls or Isolite system isolation, by selecting a preferred isolation method, etc. The treatment’s direct cost was not disclosed in any of the studies that were included. Alhareky (2014)[16] reported the variation in chair time between rubber dam and the Isolite system, whereas Ammann (2013)[17] and Loguercio (2015)[20] examined the treatment time when utilizing rubber dam or cotton rolls as the isolation method. Additionally, at baseline and during the follow-up, Loguercio 2015[20] evaluated and tracked the gingival tissue damage of the two groups (rubber dam versus cotton rolls/retraction cable).

Bias potential in studies we included

Based on assessments of high risk of bias for two domains,[16-19] or one domain, all the included studies had a high risk of bias overall.[20,21] [Table 2].

Table 2.

Rubber dam versus cotton rolls

Survival rate	No. of studies	No. of participants	Statistical method	Effect size
6 months	20,21		Odds ratio (IV, fixed, 95% CI)	2.29 [1.05, 4.99]
12 months	20		Odds ratio (IV, fixed, 95% CI)	1.38 [0.45, 4.28]
18 months	20		Odds ratio (IV, fixed, 95% CI)	1.00 [0.45, 2.25]
24 months	19	559	Hazard ratio (IV, fixed, 95% CI)	0.80 [0.66, 0.97]
Chair time	20		Mean difference (IV, fixed, 95% CI)	-0.40 [-2.26, 1.46]

Compared cotton rolls versus rubber dam

Five studies that were very susceptible to bias associated the rubber dam isolation method with the alternative isolation method—cotton rolls—and assessed 1067 people.

Primary results

Percentage of restorations that survive

In four researches,[18-21] the survival/loss rates of the restorations with rubber dam and cotton rolls isolation methods were reported. Ma (2012)[21] detailed the restoration loss rate six months after treatment. The restoration retention rates of two groups were reported by Loguercio (2015)[20] throughout follow-ups of six months, one year and one and half year, respectively, with no statistically significant variations (P > 0.05). In participants with NCCLs receiving resin composite restorative treatment at six months, the results of meta-analysis suggested that the use of rubber dams may increase the retention rate of restorations, but the evidence is conflicting (odds ratio (OR) 2.29, 95% confidence interval (CI) 1.05 to 4.99; two studies, 192 participants, 222 teeth; low-certainty evidence; Analysis 1.1). The results of a single study (Loguercio 2015)[20] indicated that there may not be a difference between the use of rubber dam and the survival rate of NCCLs at 12 months (OR 1.38, 95% CI 0.45 to 4.28; 30 participants, 60 teeth; very low-certainty evidence; Analysis 1.2) and 18 months (OR 1.00, 95% CI 0.45 to 2.25; 30 participants, 60 teeth; very low-certainty evidence; Analysis 1.3). The cumulative survival rate of dental restorations at 6, 12, 18, and 24 months was reported by Carvalho in 2010.[19] The number of reported restorations that were carried out at the beginning of the assessment period and the number of reported restorations that failed at the end of the evaluation period, however, did not line up with the reported survival rate. In this study, it was unable to use the study’s data in our analyses because of these discrepancies. Although the evidence was very shaky (hazard ratio (HR) 0.80, 95% CI 0.66 to 0.97; 559 participants; very low-certainty evidence; Analysis 1.4), Kemoli (2010)[18] showed that there might be a difference in the survival rate of dental restorations at two years favoring the use of rubber dams.

Negative incidents

None of the studies that were reviewed were included this result.

Secondary effects

Clinical assessment of the success of the restoration: According to Loguercio (2015),[20] there were no appreciable differences between the rubber dam and cotton rolls/retraction cords groups in terms of marginal staining or the adaptation of NCCLs restorations at baseline and during follow-up (6, 12, and 18 months) (P > 0.05, Fisher exact test for group comparisons and McNemar test for comparison among follow-ups).

Costs

The treatment’s direct cost was not disclosed in any of the studies that were included. However, the length of time needed for the restoration procedure was reported in two studies with a high risk of bias (Ammann 2013[17]; Loguercio 2015[20]). Ammann (2013)[17] found that utilizing rubber dams required 12.4% less time (108 seconds) to complete fissure sealing than using cotton rolls as the isolation method, after testing 72 youngsters. The mean operation time for NCCL lesions repair and its standard deviation (SD) for each group were published by Loguercio.[20] The results of the analysis revealed that there were not many differences between the groups.

Acceptance and pleasure of participants

Patients were questioned by Loguercio 2015[20] about their subjective preferences or feelings to assess the acceptability and satisfaction of participation. According to the findings, cotton rolls were preferred and accepted at a lower rate than rubber dams (P = 0.85 from a binomial test on 28 participants; very low-certainty evidence). The acceptance/satisfaction level of participants was not disclosed in the other four experiments.

The Isolite system versus the rubber dam

One included study, which had 42 participants and a high chance of bias, compared the rubber dam with the alternate isolation method, the Isolite system (IS) (Alhareky 2014).[16]

DISCUSSION

Summary of the key findings

Five studies examined the impact of rubber dam versus cotton roll isolation techniques[17-21]; the sixth study compared the Isolite system with direct restorative treatments in dental patients. This review evaluated the GRADE approach.[22] Current study has summarized this certainty assessment for the survival rates of cotton rolls against rubber dams at 6, 12, 18, and 24 months.

The impact of using rubber dams during dental restorative procedures on the durability of the restorations is still unknown. At six months after surgery (low-certainty evidence) and at 24 months after surgery (very unclear data), rubber dam isolation may favor a greater survival rate of dental direct restorations compared to typical cotton rolls. Very shaky evidence from a single, tiny study revealed that there may not have been much of an impact on the survival of restorations at 12- and 18-month follow-ups. Due to discrepancies in the reported statistics, we chose not to analyze the data for rubber dam against cotton rolls in Carvalho 2010.[19] Fissure sealant survival was not assessed by Ammann (2013).[17] The second main outcomes, adverse events, were not described in any of the included trials.

Overall evidence completeness and applicability

The reviewed studies’ identified research did not sufficiently address the review’s goals. Only participants receiving resin restorative procedures were examined in the six studies that were qualified for inclusion. There were no suitable randomized controlled trials (RCTs) or split-mouth trials that enrolled patients getting inlays, onlays, or other restorative procedures. Other included research, with the exception of Loguercio 2015,[20] did not completely report the results, making the evidence insufficient. When using rubber dams, adverse effects, direct costs, the caliber of restorations, and patient acceptance are all crucial considerations.[24-26] No studies describing side effects or the direct cost of the treatment were included, although three trials assessed the operating time costs of groups utilizing various isolation techniques.[16,17,20] Only one study evaluated the restorations’ quality at baseline and during follow-ups.[20] According to two studies, rubber dams are more widely used and more favorably received than either the innovative Isolite method or standard cotton rolls isolation.[17,20]

This study could only pool data from two studies comparing rubber dam with cotton rolls after adhesive restorations of NCCLs at six-month follow-up to address this primary outcome, despite the fact that four of the included studies described the survival/loss rate. This was primarily due to dissimilarities in the restorative treatments used, follow-up, or criteria used to define “survival/failure” among studies.

This review could not draw any firm conclusions on the benefits of rubber dam isolation for restorative treatment from the body of evidence we found. Six trials were examined, totaling 1109 participants. Because the presented data were inconsistent, it was necessary to eliminate one study from the analysis.[19] High risk of bias existed in the remaining five studies.[16-18,20,21] This study rated the evidence as very low or low certainty when such risk of bias issues was taken into account together with the fact that each outcome’s data was drawn from one or two small studies and had large confidence ranges, including no impact (leading to significant or very serious imprecision). A lack of confidence in the effect estimates can be inferred from these GRADE grades.[22,23] The estimations and our confidence in them may vary as a result of more research.

Possibly present biases throughout the review process

This study conducted a comprehensive search across different databases without regard to language to reduce bias and include all pertinent studies. However, because we did not include all the included papers in the analysis, it is possible that this biased the review’s assessment of the rubber dam isolation method’s effects. To be transparent and to give readers the freedom to draw their own conclusions, we have supplied all relevant data, justifications for the methodology employed, and our evaluations.

Two retrospective studies also discussed patient- and treatment-related variables that might influence the longevity of primary tooth restorations. The outcomes corroborated this review. By using the Kaplan-Meier curve to represent the cumulative survival distributions of all 2388 subjects over an eight-year period of follow-up, Bücher 2015[27] came to the conclusion that using dental dam reduced the risk of filling loss by a significant amount (hazard ratio (HR) =0.58, P = 0.02) overall. Similarly, Dalpian 2018 found through the survival curves that restorations placed with rubber dam demonstrated noticeably increased survival probability after enrolling 316 restorations with a 36-month follow-up.

Rubber dam usage is crucial during restorative procedures even if there is currently a lack of strong data to support its ability to increase the survival rate of dental restorations and cut down on treatment time. The use of rubber dams continues to have several benefits, including avoiding the unintentional ingestion of dental restorations or tooth fragments, shielding soft tissues from sharp objects, and assisting in child behavior control. Its crucial function in preventing patient cross-infection in hospitals, particularly for the current coronavirus disease (COVID-19) pandemic, should also be underlined. Clinicians still need to practice placing rubber dams, and it would not be appropriate to never use a rubber dam.

CONCLUSION

According to studies with low and very low certainty, the use of rubber dams may increase the survival probability of dental restorations and result in little to no difference in procedure time when associated with the conventional cotton rolls. However, given the high potential of bias in the evaluated studies, only six studies that can be analyzed, and the fact that various restorative techniques were employed in various investigations, the effects estimate should be seen with caution. Although there may be unfavorable impacts on patients from the rubber dam isolation strategy, neither positive nor negative data could be found in this review. A suitable and acceptable sample size, as well as follow-up times, should be taken into account before a trial begins. Further studies are suggested considering all the lapses enumerated in this review.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.