Schmalz 2018.
| Methods |
Trial design: parallel (6 arms) Location: Department of Cariology, Endodontology and Periodontology, University of Leipzig, Germany Number of centres: 1 Duration: between May 2015 and November 2016. Participants followed‐up at 12 weeks |
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| Participants |
Participants: a total of 162 participants were screened for eligibility, of which 150 were included into the study Inclusion criteria: healthy oral conditions (i.e. no active carious lesions, which require invasive treatment (D‐T = 0), and no periodontal treatment need (PSR/PSI ≤ 2)); a minimum number of 20 remaining teeth; age between 18 years and 30 years; ability to give informed consent and voluntary participation Exclusion criteria: age < 18 years or > 30 years; inability to participate due to severe general diseases; diseases affecting motor skills; presence of metabolic diseases (diabetes mellitus); infectious diseases (hepatitis A/B/C, HIV); renal insufficiency; seizure or neurological disorders; pregnancy; addiction (alcohol, drugs); required antibiotic prophylaxis due to endocarditis risk or immunosuppression (e.g. due to organ transplantation); dental background (dentist, dental student, or related occupation); allergies against using toothpaste or other materials used within the study; presence of dental (carious lesions with a cavitation of the tooth surface) and/or periodontal treatment need (periodontal probing depth > 3.5 mm) Age at baseline (years): all groups: 23.44 ± 2.89; Group A1 and Group A2: 22.98 ± 2.52; Group B1 and Group B2: 23.66 ± 2.95; Group C1 and Group C2: 23.70 ± 3.13 Gender: all: female 112 (81%), male 27 (19%); Group A1 and Group A2: female 38 (83%), male 8 (17%); Group B1 and Group B2: female 35 (78%), male 10 (22%); Group C1 and Group C2: female 39 (81%), male 9 (19%) Number randomised: all 150 participants. Group A1: 25; Group A2: 25; Group B1: 25; Group B2: 25; Group C1: 25; Group C2: 25 Number evaluated: all 131 participants. Group A1: 21; Group A2: 22; Group B1: 22; Group B2: 22; Group C1: 22; Group C2: 22 |
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| Interventions |
Group A1: powered toothbrush (Professional Care™ 7000, Procter & Gamble GmbH, Schwalbach am Taunus, Germany) with no instruction
Group A2: powered toothbrush (Professional Care™ 7000, Procter & Gamble GmbH, Schwalbach am Taunus, Germany) received 1 standardized instruction of the toothbrush system according to the manufacturers recommendations Group B1: powered toothbrush (SoniCare™, Philips GmbH, Hamburg, Germany) with no instruction Group B2: powered toothbrush (SoniCare™, Philips GmbH, Hamburg, Germany) received 1 standardized instruction of the toothbrush system according to the manufacturers recommendations Group C1: manual toothbrush (elmex®INTERX, CP GABA GmbH, Hamburg, Germany) with no instruction Group C2: manual toothbrush (elmex®INTERX, CP GABA GmbH, Hamburg, Germany) received instruction on 1 occasion to use the Fones technique All participants used the same toothpaste (Sensodyne® Fluoride; GlaxoSmithKline Oral Health Care GmbH, Brühl, Germany) during the whole study All groups were required to brush twice daily for 2 minutes to 3 minutes and to abandon other oral hygiene aids such as dental floss and/or interdental brushes or mouthrinses Prophylaxis provided: participants received a professional tooth cleaning including the removal of supragingival calculus, biofilm, and extrinsic discolourations as well as polishing of the tooth surfaces Member of dental team delivering intervention: dentist Frequency of intervention: instruction groups: 1 visit with OHA Intensity of intervention (length of time): not reported Setting: secondary care Disease level: healthy individuals with no active carious lesions and not requiring periodontal treatment |
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| Outcomes | Clinical outcomes: "Gingival inflammation was evaluated using the Papilla Bleeding Index (PBI) (Lange 1977) and the Gingival Index (GI) by Löe and Silness (Löe 1963). To assess PBI, gingival sulcus was spread out using a periodontal probe (PCP 15, Hu‐Friedy, Chicago, IL, USA); the PBI score ranges from score 0 (no bleeding) to score 4 (profuse bleeding). Furthermore, the GI was used to assess changes of the gingiva. A score from 0 (normal gingiva, inflammation‐free, no discolouration, no bleeding) to score 3 (severe inflammation, reddening and swelling, tendency toward spontaneous bleeding or ulceration) was used. After assessment of gingival inflammation, plaque extension was evaluated using the Plaque Index by Quigley and Hein (QHI) modified by Turesky et al after using a plaque disclosing agent (Mira‐2‐Ton®, Hager score 5 = plaque extending to the coronal third). Furthermore, the Marginal Plaque Index (MPI) by Deinzer et al was used to differentiate plaque extension at the gingival margin (Deinzer 2014). The evaluation was performed on 8 measuring points at each tooth (score 0 = no plaque; score 1 = plaque)" | |
| Notes |
Funding: "Philips GmbH (Hamburg, Germany), CP GABA (GmbH, Hamburg, Germany), and GlaxoSmithKline Oral Health Care GmbH (Brühl, Germany) for providing materials for the study" Sample size calculation: "This RCT should detect differences based on PBI and QHI of an effect size δ = 1 with a power of 80%. Under estimation of normal distribution, for a 2‐sided t test at the significance level of 5%, 20 participants in each group were required. To compensate potential dropouts, 20 to 25 participants per group should be included" Adverse effects: not reported Declarations/conflicts of interest: "The authors declare that they have no conflict of interest" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Participants were randomly divided into 3 groups (OR, SA, MTB; n = 50 each group) with 2 subgroups each: participants receiving no instructions (NI) and participants receiving instructions (I) (n = 25 per group). Randomization and attribution to groups were performed by an independent examiner (DZ). The plaque accumulation at screening examination of each patient was classified into 3 categories using the baseline modified Quigley–Hein Plaque Index (mod QHI) as follows: good (2). Based on these categories, as well as smoking habits, gender, and left‐handedness, a matching was performed according to previous studies of this working group (Schmalz 2017b; Schmickler 2014; Schmickler 2016), to ensure comparable groups" Comment: insufficient information available regarding randomisation method |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned Comment: insufficient information on allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned regarding participant blinding Quote: "With respect to their subgroup (I or NI), participants got a brush‐specific instruction (DZ)" Comment: personnel delivering intervention (DZ) would have been aware of intervention group. Blinding of participants was not possible; it is unclear the influence this would have on the risk of bias for this domain |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All study‐related examinations were performed under standardized conditions by a skilled, calibrated, and blinded dentist (kappa > 0.8, KK) in the Department of Cariology, Endodontology and Periodontology, University of Leipzig, Germany" Comment: outcome assessor blinded to participant group |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: dropouts reported and similar across intervention groups |
| Selective reporting (reporting bias) | Low risk | All outcomes reported on |
| Other bias | Low risk | No apparent other bias |