Home Oral Care With Biorepair Implant Bioactive Gel and Chlorhexidine Gel 1% for the Improvement of Inflammatory Epidemiological Indices in Periodontal Patients: a Split-mouth Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- R - Gingival recession
研究概览
简要总结
This study is an open-label split-mouth study in which periodontal patients will be treated in order to obtain periodontal health. After non-surgical therapy and air-perio polishing, a periodontal in-situ gelling product (Biorepair Implant Bioactive gel) will be applied in periodontal pockets in two quadrants (Q1-Q3 or Q2-Q4) of the mouth of the participants. At the same time, pockets of the contralateral quadrant will be irrigated with chlorhexidine gel 1%. Patients will continue to use gels at home for the following 14 days and on the same quadrants. Professional ora hygiene session will be performed after 1, 3 and 6 months from the baseline.
Patients are divided into two groups with inverted quadrants administration in order to evaluate the improvements of periodontal inflammation indices and to assess the efficacy of Biorepair Implant Bioactive gel compared to chlorhexidine 1% gel treatment.
详细描述
This study is an open-label split-mouth study that aims to assess the improvement of periodontal inflammatory indices after sessions of professional oral hygiene with the administration of Biorepair Implant Bioactive Gel and Chlorhexidine gel 1%. It will also compare the efficacy of the two gel in rebalancing periodontal health.
Periodontal patients that will give the informed consent to the treatment protocol and that satisfy the eligibility criteria will undergo 4 sessions of professional oral hygiene. For each session, periodontal inflammatory indices will be recorded and professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed, following air-perio polishing with glycine powders. At this stage, patients will be randomized and allocated to the following two groups:
- Group 1: application in periodontal pockets of quadrants Q1 and Q3 of Biorepair Implant Bioactive Gel; irrigation of periodontal pockets of quadrants Q2 and Q4 with chlorhexidine 1% gel.
- Group 2: irrigation of periodontal pockets of quadrants Q1 and Q3 with chlorhexidine 1% gel; application in periodontal pockets of quadrants Q2 and Q4 of Biorepair Implant Bioactive Gel.
Patients will continue with a home oral care protocol, using both gels for the same quadrants of their group for the following 14 days after the professional oral hygiene session.
The first session is at the baseline (T0), the second is after 1 month (T1), the third is after 3 months (T2) and the last is after 6 months (T4).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of periodontal disease according to the recent 2017 classification (2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions):
- •1.1 Severity from grade I onwards (grade I: clinical attachment loss of 1-2 mm, bone loss in the cervical third greater than 15%, no elements loss for periodontitis);
- •Complexity from grade II onwards (grade II: maximum probing depth of 5 mm, bone loss mainly horizontally);
- •Presence of bilateral periodontal probes, both to the right and to the left of the midline incisal line.
- •Subjects who gave their written informed consent to take part of the study.
排除标准
- •Patient with cardiac pacemaker
- •Patients suffering from psychological, neurological or psychiatric disorders
- •Pregnant or breastfeeding women
- •Cancer patients undergoing therapy
- •Patients taking bisphosphonates within the last 12 months
- •Patients with low compliance or inconsistent motivation
- •Drug or alcohol users
- •Presence of periodontal probes exclusively on the right or left side compared to the midline incisal line
结局指标
主要结局
R - Gingival recession
时间窗: 1, 3 and 6 months.
Evaluation (in mm) of the distance between the gingival margin and the amelo-cemental junction (JEC). It is the exposure of the root surface, following the apical migration of periodontal structure.
BOP% - Bleeding on Probing %
时间窗: 1, 3 and 6 months.
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. Percentage of sites with bleeding on probing determines the BOP%.
PPD - Probing Pocket Depth
时间窗: 1, 3 and 6 months.
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
PCR% - Plaque Control Record
时间窗: 1, 3 and 6 months.
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Dental mobility (Miller, 1985)
时间窗: 1, 3 and 6 months.
It is classified using numerical values: 0. Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; 1. Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; 2. Grade II: horizontal mobility of the tooth from 1 to 2 mm; 3. Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.
次要结局
- Comparison between biorepair gel and chlorhexidine 1% gel(1, 3 and 6 months.)
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia