NCT06738342尚未招募不适用
Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara in Patients Undergoing Periodontal Surgery: a Triple-blind, Parallel-arm, Randomized Controlled Trial
University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Oedema
研究概览
简要总结
The primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Futhermore stains, discolorations and adverse effects will be eventually recorded. Control group will be represented by the use of a CHX 0.12% mouthwash.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •More than 20 natural teeth excluding the third molars
- •Clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (PD) ≥5mm)
- •Have a full mouth plaque score (FMPS) <15% before surgery;
- •Have a full mouth bleeding score (FMBS) <15% before surgery;
- •Ability and willingness to give written informed consent;
- •Written agreement to participate in the trial.
排除标准
- •Use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation
- •Pregnancy or breastfeeding;
- •Use of medication affecting the healing process;
- •Assumption of systemic or local antibiotics in the 4 weeks before trial beginning;
- •Conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations);
- •Patients with previous periodontal treatment or who were undergoing a course of dental or orthodontic treatment will be also excluded.
- •Tobacco use (10 or more cigarettes per day)
- •Inability to comply with protocol
- •Uncooperative patient
研究组 & 干预措施
Test group
Experimental
干预措施: CHX 0.09% + Citrox + HA (Other)
Control group
Active Comparator
干预措施: CHX 0.12% (Drug)
结局指标
主要结局
Oedema
时间窗: 1, 3, 7 an 14 days
Presence of absence will be recorded (1 or 0).
次要结局
- Early Healing Score(24 hours post surgery, 3, 7 and 45 days post surgery)
- Plaque Index modified by Turesky(1,3,7 and 14 days post surgery)
- Gingival Index modified by Trombelli(1,3,7 and 14 days post surgery)
- Lobene Index modified(1,3,7 and 14 days post surgery)
- Adverse effects(1,3,7 and 14 days post surgery)
研究者
Andrea Pilloni MD DDS MS
Professor
University of Roma La Sapienza
研究点 (1)
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