Nanocrystal Gels to Treat and Prevent Peri-implant Mucositis: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Bleeding on probing (BOP)
研究概览
简要总结
This study aims to evaluate a gel's potential to improve gum health around dental implants when used alongside traditional cleaning methods. The central research question is:
Does the gel reduce gum bleeding?
Researchers will compare the effects of traditional dental cleaning alone wit those of dental cleaning combined with gel administration, focusing on overall gum health around implants. The study will enroll eight participants-some with early gum issues, such as bleeding gums, and others with healthy gums. Each participant will be randomly assigned to receive either regular dental cleaning or the cleaning paired with gel application.
The study process includes the following steps:
- Participants will visit the clinic and receive one of the two treatments randomly.
- One week later, they will complete a printed survey detailing any symptoms or discomfort experienced .
- After four weeks, participants will return to the clinic for checkups and tests to measure progress.
详细描述
This clinical study, conducted at Laval University's graduate periodontics clinic, investigates the efficacy and safety of a nanocrystal gel as a supplementary treatment to non-surgical mechanical debridement (professional cleaning) for managing peri-implant mucositis-a reversible inflammatory condition affecting the soft tissues around dental implants. The study enrolls eight participants, comprising individuals with either healthy peri-implant tissues or peri-implant mucositis. Participants are randomly assigned to one of two groups: the test group receives the nanocrystal gel in conjunction with standard peri-implant therapy, while the control group undergoes peri-implant therapy alone.
The primary focus of the investigation is the bleeding on probing (BoP) parameter, analyzing its progression over a four-week period and comparing outcomes between the two groups. Additionally, other clinical parameters, including the modified gingival index, modified plaque index, and pocket depth, are evaluated.
Participants receive one of the designated treatments, with the study design ensuring they are blinded to the specific treatment administered. A follow-up appointment four weeks later allows for the reassessment of all recorded clinical parameters. One week after treatment, participants complete a survey to report any discomfort or pain experienced post-treatment.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or older
- •Maxillary or mandibular fixed implant-supported prostheses (up to 3 units)
- •Diagnosis of peri-implant health or peri-implant mucositis
- •Signed an informed consent form
排除标准
- •Advanced peri-implantitis
- •Extensive implant-supported restorations (four units or more)
- •Recent radiotherapy, chemotherapy, long-term systemic corticosteroid therapy
- •Drugs inducing gingival hyperplasia
- •Recent antibiotics (within three months)
- •Prosthetic restorations impeding clinical assessment
- •Poor marginal contours or prosthetic complications
- •Peri-implant bone loss exceeding 30%
- •Acute oral infection
- •Uncontrolled diabetes, systemic diseases, immune deficiency, autoimmune disease
- •Long-term bisphosphonate use
研究组 & 干预措施
Test Group
This group received standard mechanical debridement around the implants with a nanocrystal gel administered topically as an adjunct treatment.
干预措施: Mechanical Debridement (Procedure)
Test Group
This group received standard mechanical debridement around the implants with a nanocrystal gel administered topically as an adjunct treatment.
干预措施: Innovative Gel application (Drug)
Control group
This group only received standard mechanical debridement around implants.
干预措施: Mechanical Debridement (Procedure)
结局指标
主要结局
Bleeding on probing (BOP)
时间窗: First assessment is the day of the intervention and the last one is 4 weeks later at follow-up.
A periodontal probe is gently inserted into the sulcus (the space between the implant and the surrounding gum tissue). The probe is moved around the implant in a sweeping motion, covering all surfaces (Mesial, Distal, Buccal and Palatal/Lingual). This gesture is done with light pressure to avoid causing unnecessary trauma to the tissues. After probing, the clinician observes the site for any bleeding. Bleeding that occurs within 10 to 15 seconds after probing is recorded as a positive BOP result.
次要结局
- Plaque index (PI)(It is assessed on intervention day and at a 4 week- follow up appointment)
- Modified Gingival Index (MGI)(It is assessed on intervention day and at a 4 week- follow up appointment)
- Probing Depth(It is assessed on intervention day and at a 4 week- follow up appointment)
研究者
Nancy Mouradian
Doctor
Laval University