Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Probing Pocket Depth (PPD)
研究概览
简要总结
This randomized controlled clinical trial (RCT) aims to evaluate the adjunctive efficacy of two domiciliary treatments in patients with periodontitis undergoing non-surgical periodontal therapy.
After signing the informed consent, patients satisfying the inclusion criteria will undergo professional supragingival and subgingival periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder.
After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy:
- Aftoral® Oral Gel containing hyaluronic acid, xylitol, and glycerophosphoinositol, applied domiciliary for 15 days.
- Unidea® chlorhexidine digluconate mouthwash 0.20%, used as a domiciliary rinse for 15 days.
The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3).
Professional oral hygiene procedures will be repeated at T2 and T3.
At each visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site:
- Gingival Recession (GR)
- Probing Pocket Depth (PPD)
- Bleeding on Probing (BoP)
- Clinical Attachment Level (CAL)
- Plaque Control Record (PCR)
- Tooth Mobility (TM)
详细描述
This is a randomized controlled clinical trial (RCT). A total of 40 patients with periodontitis are expected to be enrolled. After providing written informed consent, patients meeting the inclusion criteria will undergo supragingival and subgingival professional periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder.
All patients will be treated at the Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia (Italy).
After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy:
- Aftoral® Oral Gel, containing hyaluronic acid, xylitol and glycerophosphoinositol, applied as domiciliary treatment for 15 days.
- Unidea® chlorhexidine digluconate mouthwash 0.20%, used as domiciliary rinse for 15 days.
The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3).
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 (Outcomes Assessor)
盲法说明
The examiner assessing the periodontal clinical parameters is blinded to the treatment allocation, while participants are aware of the assigned domiciliary treatment.
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 periodontitis sites according to the 2017 World Workshop classification system
- •absence of systemic, metabolic, or autoimmune diseases
- •compliant patients
排除标准
- •neurological, psychiatric, or mental disorders
- •patients taking bisphosphonates within the last 12 months
- •patients taking antibiotics during the study period
- •pregnant or breastfeeding women
- •patients undergoing anticancer treatment
研究组 & 干预措施
Trial Group
Home treatment with hyaluronic acid.
干预措施: Aftoral Oral gel (Other)
Control Group
Home treatment with chlorhexidine.
干预措施: Unidea Chlorhexidine digluconate mouthwash 0.20% (Other)
结局指标
主要结局
Change in Probing Pocket Depth (PPD)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
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.
Change in Clinical Attachment Level (CAL)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Evaluation (in mm) of the distance of the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus or periodontal pocket, evaluated in 6 sites.
Gingival Recession (R)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Evaluation (in mm) of the displacement of marginal tissue, through a millimeter periodontal probe; it is detected from the cemento-enamel junction (CEJ) to the gingival margin.
Change in Plaque Control Record (PCR%)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100
Change in Bleeding on Probing (BOP%)
时间窗: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia