The Effect of Supragingival Biofilm Control, and the Combination of Supra and Subgingival Biofilm Control in Periodontal Health of Patients Participating in a Periodontal Preventive Maintenance Program - A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mean Attachment Loss (AL)
研究概览
简要总结
Seventy patients will be previously treated for moderate-to-severe periodontitis according to their individual needs. Thirty days after completion of periodontal treatment, these patients will be randomized to one of the following groups of periodic preventive maintenance (PPM): G1 - performed only control supragingival; G2 - performed supra and subgingival control (when necessary).
The maintenance consultations will be scheduled every 3 months for 24 months. The hypothesis is that the effect of the supragingival control (conducted over 24 months) will be similar to the effect of the supra- and subgingival control combined, above the restoration and progression of periodontitis.
详细描述
This randomized clinical trial, single-blind, aims to compare the effect of the supragingival biofilm control with the effect of supra- and subgingival biofilm control, performed by the patient-professional binomial, in periodontal patients treated, above the restoration and progression of periodontitis during the preventive periodic maintenance (PPM). Seventy patients with moderate-to-severe periodontitis, aged from 35 years, will be included. Participants will be periodontally treated according to their needs. After 30 days of the end of treatment, participants will be randomized (stratified for smoking) in two groups: Group 1 (G1)- Supragingival biofilm control; Group 2 (G2)- Supra and subgingival biofilm control. MPP consultation will take place every 3 months, for 24 months, in which the G1 will only receive procedures of supragingival biofilm control, and G2 will receive, beyond the supragingival control, subgingival interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 35 years;
- •present at least 12 teeth in the mouth;
- •patients diagnosed with moderate-to-severe periodontitis according to the criteria of the AAP (1999):
- •to present ≥ 2 interproximal sites with AL ≥ 6 mm AND ≥1 interproximal site with PD ≥ 5 mm; or
- •to present ≥ 2 interproximal sites with AL ≥ 3mm OR ≥ 2 interproximal sites with PD ≥ 5 mm (in different teeth).
排除标准
- •presence of systemic conditions unfavorable to periodontal treatment (diabetes, cardiovascular changes with antimicrobial prophylaxis indicated);
- •positive history of periodontal treatment and maintenance in the 12 months preceding the study;
- •positive history of using anti-inflammatory drugs and antibiotics in the 3 months prior to initial consultation;
- •patients in use of fixed orthodontic appliance;
- •pregnant patients.
研究组 & 干预措施
Supragingival biofilm control
干预措施: Group 1 - Supragingival biofilm control (Procedure)
Supra- and subgingival biofilm control
干预措施: Group 2 - Supra- and subgingival biofilm control (Procedure)
结局指标
主要结局
Mean Attachment Loss (AL)
时间窗: 24 months
AL: defined as the distance from the CEJ to the bottom of the pocket/sulcus.
次要结局
- Periodontal Probing Depth (PPD)(24 months)
- Microbiological markers(24 months)
研究者
Sabrina Carvalho Gomes
DDS, PhD
Federal University of Rio Grande do Sul