Yiran Peng1, Ruixian Wu2, Wenwen Qu3, Wanhong Wu4, Jiangyue Chen5, Jie Fang1, Yangxi Chen6, Mauro Farella7, Li Mei8. 1. PhD student, Department of Orthodontics, State Key Laboratory of Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. 2. Postgraduate student, Department of Biostatistics, West China School of Public Health, Sichuan University, Chengdu, China. 3. Lecturer, Biofilm Research, West China Second University Hospital, Sichuan University, Chengdu, China. 4. Research assistant, State Key Laboratory of Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. 5. PhD student, State Key Laboratory of Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. 6. Professor, Department of Orthodontics, State Key Laboratory of Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China. 7. Professor, Discipline of Orthodontics, Department of Oral Sciences, Faculty of Dentistry, University of Otago, Dunedin, New Zealand. 8. Associate professor, Department of Orthodontics, State Key Laboratory of Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China; senior lecturer, Discipline of Orthodontics, Department of Oral Sciences, Faculty of Dentistry, University of Otago, Dunedin, New Zealand. Electronic address: li.mei@otago.ac.nz.
Abstract
INTRODUCTION: Enamel demineralization and gingival inflammation are the most prevalent consequences of biofilm formation in orthodontics. Our hypothesis was that educating patients about the severe consequences of biofilm accumulation could enhance their oral hygiene while wearing fixed appliances. METHODS: This study was designed as a randomized controlled 4-arm parallel trial. A total of 148 participants in Chengdu, China, matching the eligibility criteria of 11 to 25 years of age, at least 20 natural teeth, and a treatment plan that included conventional stainless steel brackets, were randomly assigned to 4 intervention groups based on computer-generated random sequencing using simple randomization without blocking. In group A (n = 37), the subjects were shown images illustrating the severe consequences of biofilm formation, including enamel demineralization and gingival inflammation; subjects in group B (n = 40) were given biofilm disclosing tablets; those in group C (n = 38) received a combination of A and B; the subjects in group D (n = 33) served as the controls. The investigators were blinded to the allocations, and the researcher managing the random sequence did not participate in allocation or measurement. All groups received routine oral hygiene instructions. Plaque index and gingival index scores were recorded at each appointment during a 6-month follow-up. RESULTS:Eighteen participants were lost during follow-up, resulting in a total of 130 participants after the trial (group A, 35; group B, 32; group C, 34; group D, 29). No adverse events were recorded. Groups A and C exhibited a significantly lower plaque index scores (parameter-estimate [95% confidence interval] = -1.20 [-1.76 to -0.63] for group A, and -1.12 [-1.69 to -0.56] for group C) and gingival index scores (-0.13 [-0.21 to -0.04], and -0.19 [-0.28 to -0.10]), respectively, compared with group D (P <0.001 for all), whereas no significant difference was found between groups B and D, or between groups A and C (P >0.05). The adults had significantly lower plaque index (0.48 [0.13-0.84], P <0.001) and gingival index (0.06 [0.01-0.11], P = 0.018) scores than did the teenagers, and the female subjects had significantly higher gingival index (-0.06 [-0.11 to -0.01], P = 0.040) scores than did the male subjects. CONCLUSIONS: The use of images showing the severe consequences of biofilm accumulation enhanced the oral hygiene of patients treated with fixed appliances.
RCT Entities:
INTRODUCTION: Enamel demineralization and gingival inflammation are the most prevalent consequences of biofilm formation in orthodontics. Our hypothesis was that educating patients about the severe consequences of biofilm accumulation could enhance their oral hygiene while wearing fixed appliances. METHODS: This study was designed as a randomized controlled 4-arm parallel trial. A total of 148 participants in Chengdu, China, matching the eligibility criteria of 11 to 25 years of age, at least 20 natural teeth, and a treatment plan that included conventional stainless steel brackets, were randomly assigned to 4 intervention groups based on computer-generated random sequencing using simple randomization without blocking. In group A (n = 37), the subjects were shown images illustrating the severe consequences of biofilm formation, including enamel demineralization and gingival inflammation; subjects in group B (n = 40) were given biofilm disclosing tablets; those in group C (n = 38) received a combination of A and B; the subjects in group D (n = 33) served as the controls. The investigators were blinded to the allocations, and the researcher managing the random sequence did not participate in allocation or measurement. All groups received routine oral hygiene instructions. Plaque index and gingival index scores were recorded at each appointment during a 6-month follow-up. RESULTS: Eighteen participants were lost during follow-up, resulting in a total of 130 participants after the trial (group A, 35; group B, 32; group C, 34; group D, 29). No adverse events were recorded. Groups A and C exhibited a significantly lower plaque index scores (parameter-estimate [95% confidence interval] = -1.20 [-1.76 to -0.63] for group A, and -1.12 [-1.69 to -0.56] for group C) and gingival index scores (-0.13 [-0.21 to -0.04], and -0.19 [-0.28 to -0.10]), respectively, compared with group D (P <0.001 for all), whereas no significant difference was found between groups B and D, or between groups A and C (P >0.05). The adults had significantly lower plaque index (0.48 [0.13-0.84], P <0.001) and gingival index (0.06 [0.01-0.11], P = 0.018) scores than did the teenagers, and the female subjects had significantly higher gingival index (-0.06 [-0.11 to -0.01], P = 0.040) scores than did the male subjects. CONCLUSIONS: The use of images showing the severe consequences of biofilm accumulation enhanced the oral hygiene of patients treated with fixed appliances.
Authors: Gabriela Garcia; Fernando Ramos; Juan Maldonado; Antonio Fernandez; Jorge Yáñez; Lilian Hernandez; Paul Gaytán Journal: Parasitol Res Date: 2018-07-09 Impact factor: 2.289