Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite /Amino Acids and Cross-Linked Hyaluronic Acid: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Probing Pocket Depth (PPD)
研究概览
简要总结
The goal of this clinical trial is to learn if using sodium hypochlorite/amino acid gel, with or without cross-linked hyaluronic acid, as an addition to standard non-surgical periodontal therapy works to treat periodontitis in adults. It will also learn about the safety of these treatments. The main questions it aims to answer are:
Does the adjunctive treatment reduce bleeding on probing, plaque index, and periodontal pocket depth?
What medical or dental problems do participants have when receiving these treatments?
Researchers will compare:
Standard non-surgical periodontal therapy alone
Standard therapy plus sodium hypochlorite/amino acid gel
Standard therapy plus sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid ("Clean and Seal" protocol)
Participants will:
Receive their assigned treatment during one clinical session per the study protocol
Have clinical measurements taken before treatment and at three months after treatment
Be monitored for any dental or medical adverse events related to the procedures
详细描述
Detailed Description
This study is a randomized controlled clinical trial designed to evaluate the effectiveness of adjunctive therapies in the non-surgical treatment of periodontitis. The trial compares three groups:
Standard non-surgical periodontal therapy (scaling and root planing with oral hygiene instruction).
Adjunctive sodium hypochlorite/amino acid gel applied before mechanical debridement.
Adjunctive sodium hypochlorite/amino acid gel followed by cross-linked hyaluronic acid ("Clean and Seal" protocol) after mechanical debridement.
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
盲法说明
Not applicable; all procedures are open-label.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Localized periodontal pocket with a probing depth ≥ 6 mm and a clinical - attachment loss of > 3 mm (periodontitis stage III or IV; classification of the European Federation of Periodontology and American Academy of Periodontology);
- •Patients who signed the written informed consent and is willing to cooperate;
- •Bleeding on probing in more than 30% of the sites.
排除标准
- •Medical history likely to affect periodontal status and/or to compromise treatment outcomes;
- •Patients who received antibiotic and/or anti-inflammatory treatments the last 6 months
- •Patients who received immunosuppressors treatments the last 6 months;
- •Patients who received any periodontal therapy for the last 6 months;
- •Pregnant or lactating women;
- •Smokers smoking more than 10 cigarettes per day.
研究组 & 干预措施
Control group
Participants receive standard care, including oral hygiene instructions, supragingival and subgingival mechanical debridement using ultrasonic and hand instruments, and brief irrigation with 0.12% chlorhexidine solution. No adjunctive sodium hypochlorite or hyaluronic acid is used.
干预措施: Standard Non-Surgical Periodontal Therapy (Procedure)
Standard Therapy + Sodium Hypochlorite/Amino Acid Gel
Participants receive the same standard care as Arm 1. In addition, a 0.9% sodium hypochlorite/amino acid gel (Perisolv) is instilled into periodontal pockets with probing depth >4 mm and left for 60 seconds before mechanical debridement. The gel application is repeated as needed until instrumentation is complete.
干预措施: tandard Therapy + Sodium Hypochlorite/Amino Acid Gel (Procedure)
Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid
Participants receive the same treatment as Arm 2. After instrumentation, cross-linked hyaluronic acid gel (Hyadent BG) is applied to the treated pockets to promote healing and tissue regeneration, following the "Clean and Seal" protocol.
干预措施: Standard Therapy + Sodium Hypochlorite/Amino Acid Gel + Cross-Linked Hyaluronic Acid (Procedure)
结局指标
主要结局
Probing Pocket Depth (PPD)
时间窗: pre-operative and at 3 months post-operative
Probing Pocket Depth is the distance, measured in millimeters, from the gingival margin (the edge of the gum tissue) to the bottom of the periodontal pocket, which is the point where the soft tissue attaches to the tooth. It is measured using a calibrated periodontal probe at six sites per tooth: mesiobuccal, mid-buccal, distobuccal, mesiolingual/palatal, mid-lingual/palatal, and distolingual/palatal.
次要结局
- Plaque index (Silness et Loe)(pre-operative and 3 months post-operative)
- Bleeding on probing (BOP)(pre-operative and 3 months post-operative)
- gingival recession(pre-operative and 3 months post-operative)
- Clinical attachment level(Measured at baseline (T0) and 3 months post-treatment (T3).)
研究者
Marwan El Mobadder
Principal Investigator, Specialist in Periodontal and Implant Therapies
El Mobadder, Marwan, Ph.D., DDS