Treatment of Peri-implant Mucositis by Non-surgical Debridement and Adjunctive Application of a Combination of Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Change of BoP (+/-)
研究概览
简要总结
The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up. After a meticulous selection, patients will be randomly assigned to Test (Sodium Hypochlorite-based gel + NSMD + Hyaluronic Acid-based gel ) or Control (NSMD) group. All clinical parameters will be recorded and the final evaluation will be performed.
详细描述
The aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel (NaOCl gel) and a cross-linked hyaluronic acid-based gel (HA gel) as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up (Clean & Seal concept). Following the selection through inclusion and exclusion criteria, all patients will be randomly assigned to Test NaOCl-based gel + NSMD + HA-based gel) or Control (NSMD) group.
Patients will be recruited at Department of Periodontology (Univeristy of Naples "Federico II") and at Department of Periodontology (University of Budapest "Semmelweis").
Subsequently, after recording of the clinical parameters (BoP, FMPS, FMBS, PD), in the Test group a NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. Conversely, Control group will be treated only through the NSMD.
All clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again after 6 months for the final evaluation. Data analysis will be performed using statistical software.
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
- Single (Participant)
盲法说明
Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
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
- 是
入选标准
- •Age ≥ 18 years;
- •Non-smokers and smokers ( ≤ 10 cigarettes/day);
- •Presence of at least 1 implant in mucositis, clinically and radiographically detected;
- •The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed.
排除标准
- •Cancer patients;
- •Uncontrolled diabetic patients;
- •Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months;
- •Pregnant or breastfeeding patients;
- •Implants that support mobile prosthetic products;
- •Implants in peri-implantitis, detected clinically and radiographically.
研究组 & 干预措施
NaOCl + HA Group
A NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, the HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle.
干预措施: Application NaOCl gel + HA gel (Procedure)
NSMD Group
Control group will be treated only through a non-surgical mechanical therapy with curettes or scaler tips.
干预措施: Non-surgical mechanical debridement (Procedure)
结局指标
主要结局
Change of BoP (+/-)
时间窗: baseline, 6 months after periodontal therapy
Bleeding on periodontal probing
次要结局
- Change of Full-mouth Plaque Score (FMPS; %)(baseline, 6 months after periodontal therapy)
- Change of Full-mouth Bleeding Score (FMBS; %)(baseline, 6 months after periodontal therapy)
- Change of Probing Depth (PD; millimeters).(baseline, 6 months after periodontal therapy)
研究者
Luca Ramaglia
Clinical Professor
Federico II University