The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket
研究概览
简要总结
The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.
详细描述
This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated Informed Consent Form.
- •Good general health.
- •Male or female patients aged >21 years old.
- •Availability for the 25 week duration of the study.
- •Peri-implantitis is characterized by the presence of at least 1 implant with periodontal pockets of 6-10 mm in depth (potential target implant) demonstrating Bleeding on Probing without involving the apex of the implant and confirmed radiographically.
- •Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.
排除标准
- •Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study.
- •Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
- •Presence of soft or hard tissue tumours of the oral cavity.
- •Horizontal inter implant distance ≤2 mm (if an adjacent implant exists).
- •Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS).
- •History of allergy to Chlorhexidine.
- •Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
- •Patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration (excluding treatment of acetylsalicylic acid ≤100 mg /day).
- •Patients taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
- •Presence of any of the following conditions: Type 1 diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
- •The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
- •Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
- •Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.
研究组 & 干预措施
Chlorhexidine chip (Periochip®)
PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate PerioChips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm
干预措施: Chlorhexidine 2.5 mg (Drug)
Placebo chip
Placebo Chip Placebo Chips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm
干预措施: Placebo chip (Drug)
结局指标
主要结局
Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket
时间窗: Baseline to Week 24
Pocket depth is the measurement of the distance from the coronal edge of the gingival margin to the base of the pocket. Measurements were taken with a standard 15-mm University of North Carolina (UNC) periodontal probe. Change from baseline in PPD was calculated as Week 24 PPD minus Baseline PPD such that a negative difference indicates an improvement in condition
次要结局
- Clinical Attachment Levels (CAL)(Baseline to Week 24)
- Bleeding on Probing (BOP)(Baseline to Week 24)