Clinical Evaluation of 0.12% Chlorhexidine Versus MicroRepair® ABX Mouthwash in the Non-Surgical Management of Plaque-Induced Gingivitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in periodontal probing depth assessed by Probing Pocket Depth (PPD)
研究概览
简要总结
This study is designed to compare two mouthwashes used after professional dental cleaning in patients with gingivitis, a common form of gum inflammation caused by dental plaque. The two mouthwashes being studied are 0.12% chlorhexidine (CHX), which has been widely used for many years, and MicroRepair® ABX, a newer biomimetic hydroxyapatite mouthwash.
All participants will receive the same professional cleaning using the Guided Biofilm Therapy (GBT) protocol. They will then be randomly assigned to use one of the two mouthwashes twice daily for 14 days. The study will measure improvements in gum health, including reduced inflammation and plaque, and will also look at possible side effects such as tooth staining and changes in taste. Other periodontal health measures and a salivary biomarker of inflammation (active matrix metalloproteinase-8, aMMP-8) will also be assessed.
Participants will be followed for 6 months. The results will help determine whether MicroRepair® ABX can provide an effective and well-tolerated alternative to chlorhexidine for managing gingivitis.
详细描述
Gingivitis is the most common reversible form of periodontal disease, caused primarily by bacterial biofilm accumulation along the gingival margin. Chlorhexidine digluconate has long been considered the gold standard adjunct to professional oral hygiene, but its prolonged use is associated with adverse effects such as tooth staining, taste alteration, and mucosal irritation. In recent years, biomimetic hydroxyapatite-based rinses (MicroRepair® ABX) have been proposed as a well-tolerated alternative with antibacterial, remineralizing, and potential anti-inflammatory properties.
This randomized, controlled, monocentric clinical trial aims to compare the clinical and biological effectiveness of a biomimetic hydroxyapatite mouthwash (MicroRepair® ABX) versus 0.12% chlorhexidine (CHX) in patients with generalized gingivitis. Forty adult patients will be randomly assigned to receive either professional oral hygiene followed by 14 days of adjunctive use of MicroRepair® ABX mouthwash, or professional oral hygiene followed by 14 days of 0.12% CHX rinse.
The primary endpoint is the reduction of probing pocket depth (PPD). Secondary outcomes include changes in gingival bleeding assessed by the Full Mouth Bleeding Score (FMBS), dental plaque accumulation assessed by the Full Mouth Plaque Score (FMPS), clinical attachment level (CAL), gingival recession (REC), salivary levels of active matrix metalloproteinase-8 (aMMP-8), tooth staining assessed by the Lobene Stain Index, dentinal hypersensitivity assessed by the Schiff Air Index, and patient-reported taste alterations.
Patients will be followed up at 2 weeks, 1 month, 3 months, and 6 months. This study is designed to generate novel evidence on whether biomimetic hydroxyapatite can provide a clinically effective and better-tolerated alternative to chlorhexidine in the management of gingivitis.
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
- None
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
- •Adults aged between 18 and 70 years
- •Presence of generalized plaque-induced gingivitis, defined by bleeding on probing (BoP) ≥30% in the absence of clinical attachment loss, with probing pocket depth ≤3 mm at ≥90% of sites
- •At least 20 natural teeth
- •Good general health (ASA I or II)
- •Signed written informed consent
- •Willingness to comply with study protocol and attend all follow-up visits
排除标准
- •Periodontitis, defined as interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth
- •Systemic conditions known to affect periodontal status, including diabetes mellitus and immunodeficiencies
- •Antibiotic or anti-inflammatory therapy within the previous 3 months
- •Professional dental prophylaxis within the previous 3 months
- •Pregnancy or breastfeeding
- •Known allergy to chlorhexidine or MicroRepair components
- •Use of orthodontic appliances or removable prostheses
- •Smoking more than 10 cigarettes per day
- •Participation in other clinical trials within the previous 6 months
研究组 & 干预措施
MicroRepair® ABX Mouthwash Group
Participants will receive baseline clinical assessments (T0) and instructions for home oral hygiene. They will start a 14-day twice-daily regimen with MicroRepair® ABX mouthwash, containing zinc-hydroxyapatite and antibacterial agents. All participants will use a standardized sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®). At the 1-month visit (T1), they will undergo professional supragingival prophylaxis with Guided Biofilm Therapy (GBT), including plaque disclosure, ultrasonic scaling (EMS Piezon), and air polishing with glycine powder. At 3 (T2) and 6 months (T3), GBT and the home mouthwash regimen will be repeated only if the Full Mouth Bleeding Score (FMBS) remains >10%.
干预措施: MicroRepair ABX mouthwash (Drug)
0.12% Chlorhexidine Mouthwash Group
Participants will receive baseline clinical assessments (T0) and instructions for home oral hygiene. They will start a 14-day twice-daily regimen with 0.12% chlorhexidine (CHX) mouthwash. All participants will use the same standardized SLS-free toothpaste (Biorepair®). At the 1-month visit (T1), they will undergo professional supragingival prophylaxis with GBT, including plaque disclosure, ultrasonic scaling (EMS Piezon), and air polishing with glycine powder. At 3 (T2) and 6 months (T3), GBT and the home mouthwash regimen will be repeated only if FMBS remains >10%.
干预措施: Chlorhexidine 0.12% mouthwash (Drug)
结局指标
主要结局
Change in periodontal probing depth assessed by Probing Pocket Depth (PPD)
时间窗: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Periodontal probing depth (PPD) is defined as the distance from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, measured in millimeters using a calibrated periodontal probe (Hu-Friedy PCP UNC 15). PPD is assessed at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual). For each participant, a mean PPD value is calculated at each time point. Typical scores range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket), with higher values indicating more severe periodontal inflammation or attachment loss. The primary endpoint is the change in mean PPD from baseline (T0) to 6 months (T4), comparing the two intervention groups: MicroRepair® ABX mouthwash regimen versus 0.12% chlorhexidine (CHX) mouthwash regimen.
Change in periodontal probing depth assessed by Probing Pocket Depth (PPD)
时间窗: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Periodontal probing depth (PPD) is defined as the distance from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, measured in millimeters using a calibrated periodontal probe (Hu-Friedy PCP UNC 15). PPD is assessed at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual). For each participant, a mean PPD value is calculated at each time point. Typical scores range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket), with higher values indicating more severe periodontal inflammation or attachment loss. The primary endpoint is the change in mean PPD from baseline (T0) to 6 months (T4), comparing the two intervention groups: MicroRepair® ABX mouthwash regimen versus 0.12% chlorhexidine (CHX) mouthwash regimen.
次要结局
- Change in extrinsic staining assessed by Lobene Stain Index Modified(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in dentin hypersensitivity assessed by Schiff Air Index(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in taste perception assessed by a validated taste alteration questionnaire(2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in plaque accumulation assessed by Full Mouth Plaque Score (FMPS)(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in gingival inflammation assessed by Full Mouth Bleeding Score (FMBS)(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in salivary inflammation assessed by activated Matrix Metalloproteinase-8 (aMMP-8) levels(Baseline (T0), 2 weeks (T1))
- Change in gingival recession assessed by Recession (REC)(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in clinical attachment level assessed by Clinical Attachment Level (CAL)(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in plaque accumulation assessed by Full Mouth Plaque Score (FMPS)(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in gingival inflammation assessed by Full Mouth Bleeding Score (FMBS)(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in salivary inflammation assessed by activated Matrix Metalloproteinase-8 (aMMP-8) levels(Baseline (T0), 2 weeks (T1))
- Change in gingival recession assessed by Recession (REC)(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in clinical attachment level assessed by Clinical Attachment Level (CAL)(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in extrinsic staining assessed by Lobene Stain Index Modified(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in dentin hypersensitivity assessed by Schiff Air Index(Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
- Change in taste perception assessed by a validated taste alteration questionnaire(2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia