Evaluation of Hyaluronic Acid and Chlorhexidine Gel as an Adjunct to Minimally Invasive Non-surgical Therapy in the Treatment of Stage III and IV Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Probing pocket depth
研究概览
简要总结
Stage III and IV periodontitis are advanced forms of periodontal disease characterized by significant attachment loss, deep periodontal pockets, and progressive destruction of supporting periodontal tissues. Minimally invasive non-surgical therapy (MINST) has been proposed as an effective treatment approach aimed at minimizing tissue trauma while achieving optimal biofilm and calculus removal. Adjunctive therapies may further enhance clinical outcomes by promoting wound healing and reducing inflammation.
This randomized clinical trial aims to evaluate the effectiveness of a hyaluronic acid and chlorhexidine gel (Periofix Plus Gel) used as an adjunct to MINST in patients with Stage III and IV periodontitis. Participants will be randomly assigned to receive either MINST alone or MINST combined with local application of the hyaluronic acid/chlorhexidine gel. Clinical periodontal parameters, including probing pocket depth, clinical attachment level, bleeding on probing, and plaque-related indices, will be assessed at baseline and follow-up visits to determine whether adjunctive gel application provides additional clinical benefits compared with MINST alone.
The study hypothesis is that the adjunctive use of hyaluronic acid and chlorhexidine gel following MINST will result in greater periodontal pocket reduction, improved clinical attachment gain, and enhanced soft tissue healing compared with MINST alone.
详细描述
A tendency to perform increasingly less traumatic procedures (like MINST) that preserve hard and soft periodontal tissues is being observed in periodontology, significantly improving the visualization and root decontamination, reducing inflammation and probing depth, and at the same time preserving the gingival margin and consequently improving the aesthetic results.
In the literature, extracellular matrix components and various local agents have been explored as adjuncts to periodontal treatment. The unique physiochemical properties of hyaluronic acid (HA) have led to its frequent use in medical applications for many years. HA, a natural extracellular matrix constituent, plays a crucial role in periodontal health. It has anti-inflammatory, anti-edematous, and antibacterial properties particularly in relation to periodontal diseases arising from the interplay between the host and microbial dental biofilm. Studies suggest that HA enhances the viability of periodontal ligament (PDL) cells, preserves osteogenic differentiation, strongly promotes the proliferation of osteoprogenitor cells, and potentially aiding in regeneration of periodontal bone defects.
CHX is the most potent chemical plaque control agent that has various clinical applications in periodontics. Its broad antimicrobial spectrum can be considered as boon for maintaining overall oral health. Moreover, CHX has proven to be an extremely useful antimicrobial in the field of health. Locally administered and sustained CHX in the form of CHX chips is the most advantageous for long-term use as an adjunct to oral hygiene in patients with periodontitis (stage I-III).
The control group will receive MINST only for the treatment of deep periodontal pockets. The application of MINST minimizes soft and hard tissue trauma achieving better treatment outcomes in comparison with traditional scaling and root planing. Gingival architecture is maintained, and stability of the area is preserved favoring better clot formation and stabilization.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-70
- •Diagnosis of 'periodontitis' stage III or IV (grades A to C)
- •Presence of ≥ 1 'intrabony defect' (PPD, > 5 mm with intrabony defect depth ≥ 3 mm at screening radiograph)
- •Signed informed consent
排除标准
- •Smoking (current or in past 5 years)
- •Medical history including diabetes or hepatic or renal disease or other serious medical conditions or transmittable diseases
- •History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- •Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
- •Systemic antibiotic therapy during the 3 months preceding the baseline exam
- •History of alcohol or drug abuse
- •Self-reported pregnancy or lactation
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation
- •Periodontal treatment to the study site within the last 12 months
研究组 & 干预措施
Control
The control group will receive MINST only for the treatment of deep periodontal pockets. The application of MINST minimizes soft and hard tissue trauma achieving better treatment outcomes in comparison with traditional scaling and root planing. Gingival architecture is maintained, and stability of the area is preserved favoring better clot formation and stabilization
干预措施: MINST (Procedure)
Test
Test intervention (MINST + CHX+HA gel): Participants will receive Minimally Invasive Non-Surgical Therapy (MINST) for the treatment of deep periodontal pockets. Immediately after instrumentation, a chlorhexidine (CHX) and hyaluronic acid (HA) gel will be applied subgingivally into the treated periodontal pockets as an adjunct to MINST. The gel is intended to provide local antimicrobial activity while supporting soft tissue healing and periodontal wound repair. Gel used: Periofix Plus GEL (Intermed S.A. Pharmaceutical Laboratories, Greece)
干预措施: MINST + CHX+HA gel (Procedure)
结局指标
主要结局
Probing pocket depth
时间窗: 0, 3, 6 months
Measured from the gingival margin to the bottom of the gingival sulcus. Each tooth will be probed with a light force not exceeding 25 grams at 6 sites
次要结局
- Clinical attachment level (CAL)(0, 3, 6 months)
- Bleeding on probing(0, 3, 6 months)
- Gingival Marginal Level (GML)(0, 3, 6 months)
- Plaque index(0, 3, 6 months)
- Post-operative Pain(7 days)
研究者
Abdallah Mamdouh Kamal Ali
Master's degree candidate, Cairo University
Cairo University