Clinical Effectiveness of Oxygen-Releasing Oral Gel as an Adjunct to Scaling and Root Debridement in Patients With Severe Periodontal Pockets: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Probing pocket depth (PPD)
研究概览
简要总结
The goal of this clinical trial is to learn if adding an oxygen-releasing gel to a deep dental cleaning treatment can improve gum health more than deep cleaning alone, in adults with severe gum disease. The main questions it aims to answer are:
- Does adding oxygen-releasing gel to deep cleaning reduce the depth of gum pockets more than deep cleaning alone?
- Does adding oxygen-releasing gel to deep cleaning lead to greater improvement in gum attachment, less gum recession, less plaque, and less bleeding, compared to deep cleaning alone?
- Do any improvements last for up to 6 months?
Researchers will compare one side of each participant's mouth, treated with deep cleaning plus oxygen-releasing gel, to the other side, treated with deep cleaning alone, to see if adding the gel produces a bigger and longer-lasting improvement in gum health.
Participants will:
- Attend 5 visits over 6 months
- Receive deep cleaning (scaling and root debridement) on both sides of the mouth at visits where it is needed
- Have one side of the mouth randomly chosen, using a method similar to drawing lots, to also receive the oxygen-releasing gel
- Receive the gel twice: once at the first visit, and again one week later
- Have their gum measurements checked at each visit
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Systemically healthy individuals or individuals with a well-controlled systemic condition
- •Individuals 18 years of age or older
- •No restrictions on gender
- •Individuals diagnosed with periodontitis and present with a localised or generalised distribution of deep pockets
- •There is presence of more than one qualifying severe periodontal pocket measuring ≥ 6 mm
- •There must be at least two qualifying severe pocket profiles present (one for the experimental site and one for the active control site)
排除标准
- •Individuals who have received any form of non-surgical or surgical periodontal therapy within the past 6 months
- •Smokers or tobacco chewers
- •Pregnant or lactating mothers
- •Individuals who have received systemic antibiotic therapy within the past 3 months
- •Individuals who require prophylactic antibiotic coverage prior to dental procedures
- •Individuals who are currently using topical antiseptics
- •Currently on antiplatelet or anticoagulant therapy
- •Individual with bleeding disorder
研究组 & 干预措施
Test Group
This study will involve 2 arms in every patient since it will be a split-mouth study. The test arm is the second arm in the same patient but at a different tooth site (test site) which will receive standard treatment plus adjunctive therapy (oxygen-releasing oral gel / blue®m Oral Gel).
干预措施: Topical oxygen-releasing oral gel (Drug)
Control Group
This study will involve 2 arms in every patient since it will be a split-mouth study. The first arm (control site) will involve standard treatment (scaling and root debridement) for periodontitis.
干预措施: No intervention (Other)
结局指标
主要结局
Probing pocket depth (PPD)
时间窗: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
The distance measured from the gingival margin to the base of the periodontal pocket. This will be assessed at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) using a standardised UNC-15 periodontal probe exerted with approximately 0.25 N of probing force. It will be recorded in millimetres.
Clinical Attachment Level (CAL)
时间窗: Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review
The distance measured from a fixed anatomical reference point, the cementoenamel junction (CEJ), to the base of the periodontal pocket. It is calculated using the formula: CAL = PPD + Gingival Recession (or PPD - Gingival Overgrowth). It will be measured at the same six sites per tooth using a standardised UNC-15 probe. It will also be recorded in millimetres.
次要结局
- Bleeding on Probing (BOP)(Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review)
- Plaque Score(Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review)
研究者
Anis Izzati binti Abdul Aziz
Dr
Universiti Sains Malaysia