Comparison of 0.2% Chlorhexidine and MicroRepair ABX Mouthwash in Patients With 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
Gingivitis is the most common form of reversible gum disease, caused by the accumulation of dental plaque. It leads to inflammation of the gums, bleeding, and discomfort, but it can be managed and reversed with professional dental cleaning and proper oral hygiene.
Chlorhexidine 0.2% mouthwash is considered the "gold standard" in reducing plaque and gingival inflammation. However, its long-term use may cause side effects such as tooth staining, changes in taste, and irritation of the oral tissues. MicroRepair® ABX mouthwash, which contains biomimetic zinc-hydroxyapatite microcrystals with antibacterial components, has shown promising properties in reducing plaque and supporting gum health, with potentially fewer side effects.
This randomized controlled clinical trial will compare the effectiveness of 0.2% chlorhexidine mouthwash and MicroRepair® ABX mouthwash, both used after professional dental cleaning, in patients with plaque-induced gingivitis. Forty participants will be randomly assigned to one of the two treatments for 14 days.
The primary outcome will be the change in gum pocket depth, measured as Probing Pocket Depth (PPD). Secondary outcomes include changes in plaque accumulation, measured as Full-Mouth Plaque Score (FMPS); gum bleeding, measured as Full-Mouth Bleeding Score (FMBS); attachment of the gums to the teeth, measured as Clinical Attachment Level (CAL); gum recession, measured as Recession (REC); tooth staining, measured with the Lobene Stain Index; tooth sensitivity, measured with the Schiff Air Index; taste alterations assessed through a validated questionnaire; and salivary levels of activated Matrix Metalloproteinase-8 (aMMP-8), a biomarker of gum inflammation.
The goal of this study is to determine whether MicroRepair® ABX is as effective as chlorhexidine 0.2% in treating plaque-induced gingivitis, while offering better tolerability and fewer side effects.
详细描述
Gingivitis is a reversible inflammatory condition of the gums, caused by the accumulation of dental plaque. It is characterized by gum redness, swelling, and bleeding, but it does not involve loss of attachment or bone support. Although it can be effectively managed, untreated gingivitis may progress to periodontitis, which is a more severe and irreversible disease.
Chlorhexidine digluconate 0.2% is widely regarded as the gold standard among antiseptic mouthwashes because of its proven antibacterial and anti-plaque properties. Nevertheless, its long-term use is limited by adverse effects, including tooth and tongue staining, altered taste perception, and mucosal irritation. For this reason, alternative formulations with similar antibacterial potential but fewer side effects are under investigation.
MicroRepair® ABX mouthwash contains biomimetic zinc-hydroxyapatite microcrystals enriched with antibacterial agents. Zinc-hydroxyapatite has shown the ability to reduce plaque accumulation, promote enamel remineralization, and support gum health without cytotoxic effects. Despite encouraging in vitro results and clinical studies in other conditions, there is still a lack of randomized controlled trials directly comparing MicroRepair® ABX with chlorhexidine 0.2% in patients with plaque-induced gingivitis.
This study aims to fill this gap by evaluating whether MicroRepair® ABX is as effective as chlorhexidine 0.2% in reducing gingival inflammation after professional dental cleaning. In addition to standard clinical measures-such as Probing Pocket Depth (PPD), Full-Mouth Plaque Score (FMPS), Full-Mouth Bleeding Score (FMBS), Clinical Attachment Level (CAL), and Recession (REC)-the trial will also assess patient-related outcomes including tooth staining (Lobene Stain Index), dentinal sensitivity (Schiff Air Index), and taste alterations. Furthermore, salivary levels of activated Matrix Metalloproteinase-8 (aMMP-8), a sensitive biomarker of periodontal inflammation, will be analyzed to provide insight into the biological mechanisms of action.
By integrating both clinical and biomolecular outcomes, this study will generate robust evidence on whether MicroRepair® ABX can serve as a safe and effective alternative to chlorhexidine 0.2% in the management of plaque-induced 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 (FMBS ≥ 25%, PPD ≤ 3 mm in ≥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 CAL ≥1 mm at ≥2 non-adjacent teeth)
- •Systemic diseases affecting periodontal status (e.g., diabetes, immunodeficiencies)
- •Antibiotic or anti-inflammatory therapy in the last 3 months
- •Professional dental cleaning in the past 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 in the past 6 months
研究组 & 干预措施
MicroRepair ABX Mouthwash
Participants assigned to this arm will receive professional dental cleaning at baseline (T0). After this visit, they will use MicroRepair® ABX mouthwash, which contains biomimetic zinc-hydroxyapatite microcrystals enriched with antibacterial agents. The prescribed regimen is 10 mL of mouthwash for 30 seconds, twice daily, for 14 days, after toothbrushing, without rinsing with water for at least 1 hour.
Follow-up visits will be scheduled at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4). At each visit, periodontal parameters and patient-reported outcomes will be recorded. Salivary samples for activated Matrix Metalloproteinase-8 (aMMP-8) analysis will be collected at T0 and T1.
干预措施: MicroRepair ABX mouthwash (Drug)
0.2% Chlorhexidine Mouthwash
Participants assigned to this arm will receive professional dental cleaning at baseline (T0). After this visit, they will use chlorhexidine digluconate 0.2% mouthwash, considered the gold standard for chemical plaque control. The prescribed regimen is 10 mL of mouthwash for 30 seconds, twice daily, for 14 days, after toothbrushing, without rinsing with water for at least 1 hour.
Follow-up visits will be scheduled at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4). At each visit, periodontal parameters and patient-reported outcomes will be recorded. Salivary samples for activated Matrix Metalloproteinase-8 (aMMP-8) analysis will be collected at T0 and T1.
干预措施: Chlorhexidine 0.2% 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 with 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 score is calculated at each time point (T0, T1, T2, T3, T4). Possible PPD scores typically range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket). A higher score indicates more severe gingival inflammation or periodontal attachment loss. The primary endpoint is the change in mean PPD from baseline (T0) to 6 months (T4), comparing the two groups: MicroRepair® ABX mouthwash regimen vs chlorhexidine digluconate 0.2% mouthwash regimen. All participants receive supragingival prophylaxis according to the Guided Biofilm Therapy (GBT) protocol.
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 with 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 score is calculated at each time point (T0, T1, T2, T3, T4). Possible PPD scores typically range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket). A higher score indicates more severe gingival inflammation or periodontal attachment loss. The primary endpoint is the change in mean PPD from baseline (T0) to 6 months (T4), comparing the two groups: MicroRepair® ABX mouthwash regimen vs chlorhexidine digluconate 0.2% mouthwash regimen. All participants receive supragingival prophylaxis according to the Guided Biofilm Therapy (GBT) protocol.
次要结局
- 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))
- 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 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 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