Novel Use of Tranexamic Acid to Reduce Time Taken During Bracket Placement for Orthodontic Traction of Impacted Teeth: An Observational Study

Abstract

Background and Aim

Therapeutic surgical exposure and placing a bracket on the impacted tooth is an approach which involves both maxillofacial surgeon and an orthodontist. The prime requirement is complete hemostasis and isolation which sometimes is difficult to achieve. This study was conducted to evaluate the efficacy of topical application of Tranexamic acid (TA) intra-operatively to facilitate this Procedure. Time, duration from exposure of the crown of the impacted tooth to bonding of brackets, allergic reactions, intra-operative blood loss, surgeon’s perception and patient’s comfort were the criteria’s which were evaluated.

Method

This prospective observational study had two groups, for which 10 patients selected with impacted teeth. In first group topical application of TA soaked gauze pieces were used, and in second group normal saline soaked gauze pieces were used as control.

Results

Statistically significant results were achieved for experimental group in terms of Intra operative time duration and intra operative blood loss which inferenced that better isolation was achieved with the local use of Tranexamic acid, Surgeon’s perception was good which inferenced that Surgeon was more comfortable in experimental group, Also Patients were more comfortable and postoperative wound healing was better in experimental group and no adverse reactions were reported in any group.

Conclusion

Topical use of tranexamic acid achieved better results for therapeutic surgical exposure showing good isolation for bonding the brackets. This technique is very cost effective, easy to apply with no adverse effects. With additional use of hemostatic agent topically; reduction in time duration, less bond failure, uneventful healing and improved patient’s and surgeon’s satisfaction is achieved.

Introduction

The most commonly impacted tooth other than third molars is the maxillary canine and it often requires exposure and application of bracket to apply traction [1]. There is a 2:1 incidence among females over males and a 2 to 3 times higher likelihood of palatal versus labial impaction. The incidence of maxillary impaction has been reported to be between 1 and 5% in different populations. A lower frequency has been noted among Blacks and Asians and there is a higher occurrence in Greeks and Turks with European Caucasians somewhere in between [2]. Orthodontists and Surgeons often collaborate in the exposure of unerupted ectopic teeth to apply orthodontic traction for their alignment. Two options are generally available: (1) exposure of the tooth and bonding something to be used to apply traction (e.g., ligature, gold chain) and (2) exposure only [3].

Exposure of Impacted tooth and Placement of orthodontic bracket is a common procedure done at our institutes & clinics. The oozing at the site and inability to achieve good isolation leads to increased time and frequent bond failures which are a very well encountered disadvantage. The problems encountered include de-bonding of the attachment: 4.3% immediately after placement of bracket and inability to bond the attachment during surgery: 1.4%. [4]. Blood contamination during bonding can lead to premature failure of the bond. Even momentary saliva or blood contamination adversely affects the bond. This is because saliva and blood deposit an organic adhesive coating within the first few seconds of exposure which is resistant to washing. [5]

These problems were recognized, identified and worked upon and a simple solution was hypothesized of applying tranexamic acid to the local site. This observational study was conceptualized and designed to verify our hypothesis. This intervention was done to reduce the time taken for bracket placement, easing this procedure and reduce failure rate, which can be done by maintaining the adequate hemostasis of the environment and thus achieving good isolation which is the prime requirement for achieving our aim.

To achieve good isolation and to reduce the time duration from exposure of the crown of the impacted tooth and facilitating bonding of bracket various drugs are used. Administration of anti-fibrinolytic agents such as Aprotinin, calcium sulfate (CaS), Amino caproic acid and Tranexamic acid preoperatively to stabilize the multiple micro clots that form within the surgical wound. [6]

Tranexamic acid is used as hemostatic agent both locally and systemically. It is derived from the amino acid lysine. It produces the anti-fibrinolytic effect. It reversibly blocks lysine binding sites on plasminogen molecules. Lysine exerts its anti-fibrinolytic effect by competitively inhibiting the activation of plasminogen thereby reducing the conversion of plasminogen to plasmin. It can also directly inhibit plasmin activity. Lastly, the previously transported coagulation factor VII and tissue factor coming from a vascular injury work together to activate tissue factor: coagulation factor VII. This enzyme helps coagulation factor X to Xa, to contribute to the prothrombinase complex and complete the pathway. The most common application of topical Tranexamic acid in oral and maxillofacial surgery is in patients with congenital or acquired coagulation disorders. [7]

Purpose of the paper is to draw attention to a simple process of applying Tranexamic acid as a local agent to facilitate isolation so as to ease the bonding of brackets thus reducing problems associated with it. (Fig. 1)

Fig. 1.

An OPG depicting an impacted canine

Null Hypothesis

There is no difference in time taken to bond a bracket, intra operative time taken, patient comfort, allergic reactions; during the therapeutic placement of brackets for the purpose of applying traction to bring the impacted tooth to its normal position in experimental and control groups.(Fig.2

Fig. 2.

Exposed bonded canine

Study Design

Observational Study (with Experimental and Control Group).

Place of Study

Department of Oral & Maxillofacial Surgery ******

Source of Data

The present study was carried out on patients who required therapeutic surgical exposure of impacted teeth reporting to Department of Oral and Maxillofacial Surgery & Department of Dento-facial Orthopedics at our college.

Related Approvals

From department of Orthodontics, & HRRP & Ethics Committee. Approval-SVIEC/ON/DENT/BNPG15/D16035, COMPLETION NO:SVIEC/ON/DENT/BNPG16/D17055).

Sample Description

Total sample size of 10 patients was calculated and these patients were divided into 2 groups of 5 patients each. Since the sample size is small nonparametric tests were applied to calculate the results.

Selection Criteria

Inclusion Criteria

The patients with age group of 10 to 50 years, with no known history of bleeding disorders and no Known allergy to any drug having impacted canine in maxilla or/and mandible, indicated for bracket placement. [8]

Exclusion Criteria

Patients with underlying systemic diseases and patients on anticoagulants.

Methodology

• A detailed case history of each patient was recorded and patients indicated for surgery were taken and allotted to one of the groups.

• Consent for surgery and Local anesthesia was taken from patient and his/her relatives, Routine blood investigations and radiographs were done.

• Patch test for local anesthesia and Patch test for Tranexamic acid (0.3 – 0.5 ml) was done intradermally on different days, and looked after for 20 min for any reaction, prior to its use in the surgical procedure. [9]

• Radiographs were done and Tube shift technique was applied to identify the impactions into Buccal or Palatal.

Surgical procedure

• All procedures were done under aseptic coverage.

• Intraoral irrigation with Betadine solution and normal saline was done. Painting and draping was done. Local anesthesia was given.

• Nerve Blocks with lignocaine with adrenaline were given in all patients to avoid the bias of local infiltration.

• Same surgeon operated all the cases.

• Crevicular Incision was placed using15 no. BP blade. Full thickness mucoperiosteal flap were reflected.

• Local application of Tranexamic acid was done at the operating site after exposure in soft tissue impactions or after bone removal in case of bony impactions with the help of cotton gauze (500 mg/5 ml) and was kept for 3 min. [10]^,11^, 12

• Impacted teeth were exposed by either reflecting the full thickness mucoperiosteal flap only in case of soft tissue impactions or by removing (guttering) the overlying bone around the impacted teeth.

• Once isolation was achieved and maintained, brackets placement was done followed by attachment of ligature wire over the brackets.

• The following parameters were recorded.

• Time duration (placement of incision to the placement of the bracket),

• Intra-operative blood loss (< ~ 5 ml or >  ~ 5 ml loss of blood

• Patient’s discomfort, (Absent or Present)

• Allergic reaction to adjacent tissue,

• Surgeon’s perception, (no difficulty, minor difficulty, moderate difficulty, severe difficulty)

Intra-operative blood loss was decided by the following method:

• The weight of the swabs before and immediately after being discarded intra-and postoperatively (1 g = 1 ml)

• The volume (V) of irrigant fluid used during the operation. At the beginning of each operation, a known volume of normal saline (V original) was used for irrigation and cooling off instruments and also for debridement at the end of the procedure. This fluid was collected from the operative field by high volume suction. At the end of the operation, the difference between the total volume collected (V final) in the aspirator jar and the original irrigant volume used was taken as the amount of blood loss (V blood).

• management of allergic reactions as per the Given Protocols were followed

Result

We have used chi square test to find significance level between the groups.

• It shows time taken for the surgery; 5 out of 5cases were done in less than 40 min of time in group A and 5 out of 5 cases were done in greater than 40 min of time in group B. The p value (0.001) was statistically significant. Table 1

• It shows evaluation of allergic reactions preoperatively and postoperatively in both the groups. As the allergic reactions were absent (0%) in the both group A and group B, so p value cannot be calculated as both the groups were constant.

• It shows that intra operative blood loss in group A patient was <  ~ 5 ml in 3 patients (30%) and >  ~ 5 ml in 2 patients (20%) and intra operative blood loss in group B patient was >  ~ 5 ml in all 5 patients (50%). The p value (0.001) was statistically significant. Table 2

• It shows that surgeon’s perception was good in group A patients with No difficulties in 3 patients and Minor in 2 patients. Surgeon’s perception was not good in group B with minor difficulties in 4 patients and moderate difficulties in 1 patient. The p value (0.001) was also statistically significant. Table 3

• It shows present value of patient’s discomfort in both the groups. Discomfort was absent in all 5 patients of group A. It was present in 3 out of 5 patients. The p value (0.001) was statistically significant in this group also. Table 4

Table 1.

Time duration (placement of incision till the placement of the bracket),

Surgery Time
Sr No	Group	< 40 min	> 40 min	P value
1	A	5 (50%)	0	0.0001
2	B	0	5 (50%)

Table 2.

Intra-operative blood loss (< ~ 5 ml or >  ~ 5 ml loss of blood)

Intra-operative Blood Loss
Sr No	Group	<  ~ 5 ml	>  ~ 5 ml	P value
1	A	3 (30%)	2 (20%)	0.0001
2	B	0	5 (100%)

Table 3.

surgeon’s perception, (no difficulty, minor difficulty, moderate difficulty, severe difficulty)

Surgeon Perception
Sr No	Group	No Difficulty	Minor Difficulty	Moderate Difficulty	Severe Difficulty	P value
1	A	3 (30%)	2 (20%)	0 (00%)	0 (00%)	0.0001
2	B	0 (00%)	4 (40%)	1 (10%)	0 (00%)

Table 4.

Patient’s discomfort, (Absent or Present)

Patient Discomfort
Sr No	Group	Yes	No	P value
1	A	0	5 (100.00%)	0.0001
2	B	3 (30.00%)	2 (20.00%)

Discussion

When the tooth fails to erupt within the oral cavity beyond its chronological age limit and its complete root formation it is called as impacted tooth. This study is done to assess the ease of operation and decrease in time taken for applying a bracket which is an inherent step toward bringing the tooth in oral cavity. As the face is a highly vascular, chance of bleeding increases. Excessive bleeding may lead to reduced accessibility and visibility and decreased isolation which leads to prolonged surgical time. To prevent failure of the bond, tranexamic acid in the form of topical agent was used in this study to simplify the procedure [4]. Tranexamic acid is used topically during the surgery because Tranexamic acid is approximately 10 times more potent and has a longer half-life than Aminocaproic acid. In this study, we used gauze piece soaked in injectable form of tranexamic acid (500 mg/5 ml). [11]. [12],13, [14]^, [15], [16]^.

A Null hypothesis was hypothesized and results lead to the rejection of null hypothesis as we had significant P values in our comparison between 2 groups inference that TA is a better option for achieving isolation. This observational study included total 10 patients. These 10 patients were divided into two groups, containing 5 patients each group. In group A (experimental group), local application of tranexamic acid was done, in group B (control group) normal saline was used a. Both the genders were included in this study.

In group A, out of five, one male and four female patients, with mean age of 21.8 years. In group B, out of five, one male and four female patients with mean age of 21 years. Thus, the frequency of the male patient was 20% and of the female patient was 80% in both the groups. Surubhi Kumar et al [17] also conducted study and found that Impactions were twice as common in females (1.17%) as in males (0.51%).We could not find a case of impacted central incisor or impacted premolars which required orthodontic correction. In group A & B, three patients had buccally placed and two patients had palatally placed teeth. Thus, the frequency of buccally placed teeth was 60% and for palatally placed teeth were 40% in group A Thus the frequency was same as group one. Ranjit Manne et al [12] conducted study and found that one-third of impacted maxillary canines were located buccally and two-thirds were located palatally. Most of the time, palatal displacement of the maxillary canine results in impaction. Our study was in contrast to the regular literature present today.

Number of attempts for Bonding of brackets was also calculated in the study. In group A, in which we had used tranexamic acid locally, had shown some good results with less bleeding and provided isolation immediately so that we were able to put brackets in a first go and faster; thus, reducing the time duration of the surgical procedure. In group B, we had used normal saline locally and we found difficulty in maintaining isolation and this resulted in taking larger time for bonding the brackets and also multiple attempts were required in same patients.

Time taken for the surgery was also analyzed in the study. The time period was calculated from the placement of incision till the placement of the brackets in both the group. In group A, where we had used local tranexamic acid with the help of soaked gauze pieces (500 mg/5 ml) for 3 min. [10]^,11^, [18] In group one, the time taken for the surgery was less than 40 min in all 5 patients. The mean time of the group one was 33 min. In group B, the time taken for the surgery was more than 40 min in all 5 patients. The mean time of the group two was 46.2 min. The p value (0.001) was statistically significant. And our study correlates with study performed by Hossein et al. [11] (P < 0.001).

Intra operative blood loss: The intra-operative blood loss was less than ~ 5 ml in 3 out of 5 patients in experimental group and was ~ 6 ml in 2 remaining 2 patients. The intra-operative blood loss was more than ~ 5 ml in all 5 patients of the controlled group. We excluded patients with bleeding disorders in the study, and all the patients were having normal blood profile. The p value is (0.001) which was statistically significant. Reza Zahed et al. [19] (P < 0.001) and Tibbelin A et al. [15](P < 0.001) conducted the study with local application of tranexamic acid in bleeding control and found good results. Mark D. Utkewicz et al. [13] (p < 0.00 1) also conducted the use of tranexamic acid soaked gauze in bleeding control and had good results. Lillian Tengborn et al. [20] had performed the study by using topical tranexamic in achieving hemostasis and inferred that good hemostasis can be achieved; which further substantiates our results.

Allergic reactions were analyzed pre- and postoperatively in each group. Preoperative allergic reactions were analyzed based on patch test. We injected 0.3 – 0.5 ml of drug intracutaneously in the forearm and checked for any localized allergic reaction. Allergic reaction was also analyzed immediate postoperatively and in follow ups also in the form of fibrosis, delayed healing or tissue necrosis. None of the patient in each group had any allergic reaction pre- or postoperatively. The p value cannot be calculated as the parameter was constant in both the group. Reza Zahed et al [19] performed study with local application of tranexamic acids soaked gauze piece in epistaxis and found no adverse reactions. Jinqian Liang [16]had used tranexamic acid soaked absorbable gelatin sponge and found no adverse reactions and these results correlate with our study results. K. Ausen et al [14] had used topical tranexamic acid in reduction mammoplasty and found no adverse effect.

Surgeon’s perception was evaluated in this study postoperatively. The surgeon was satisfied with the ease of procedure, postoperative outcomes in the experimental group. Whereas in controlled group the surgeon required rebonding of the brackets in two patients, within 4 days which lead to delayed wound healing. Since all patients were treated by one surgeon so observational bias was zero, surgeon’s opinion was verbatim. Thus, additive use of tranexamic acid provided better results and reduced intra-operative time and patient’s discomfort also. Mohammad Hossein et al [11] and Meeran et al [21](P < 0.001) conducted study with topical tranexamic acid in sinus surgery and had found good surgeon’s perception and satisfaction.

Patient’s discomfort was evaluated postoperatively as present or absent. All the patients who had been treated under experimental group had good postoperative wound healing with, no tissue necrosis and bond failure. While in group two the healing was little compromised in two patients and also in two cases where rebonding was done. Thus, patient’s discomfort was less in experimental group as compared to the controlled group which may be attributed to the less operating time and less attempts required for bonding. Thus, p value (0.001) was statistically significant.

The Strengths and Outcomes of our study lies in the results which speak for themselves and we believe that it is first of its kind studies. The major weakness lies with the sample size; although we derived at the sample size with the statistician's advice and a proper procedure was followed to complete the study and attain the results. Also, nonparametric tests were performed, which as such are indicated for small sample studies to calculate the results.

Conclusion

With the help of tranexamic acid, we can achieve better isolation and dry field which reduces time taken for proper bonding of the brackets. This technique is very cost effective, easy to perform with no adverse effects. With additional use of hemostatic agent topically, less chances of bond failure, uneventful healing and improved patient’s and surgeon’s satisfaction. Although the results in our study are favorable; we need to conduct a study with a larger sample size to substantiate these results.

Declarations

Conflict of Interest

The authors have that they declare no conflict of interest.