Propolis-Based Solution Application in Extraction Socket Healing: A 3D Split-Mouth Clinical Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Percentage of Extraction Socket Surface Area Closure
研究概览
简要总结
This pilot study evaluated whether a propolis-based topical solution improves soft-tissue healing after tooth extraction. Thirteen patients requiring extraction of two comparable teeth on opposite sides of the mouth were enrolled in a split-mouth design, in which one extraction site received the propolis solution while the other served as an internal control. The test site was treated with the propolis solution three times daily for seven days, while the control site received only saline rinses. Healing was tracked using 3D intraoral scans obtained before extraction and on days 7 and 14 afterward, allowing the percentage of socket closure to be measured objectively over time. Postoperative pain was also assessed using a standard visual pain scale on days 1, 3, and 7. The study aimed to determine whether this propolis-based formulation could serve as a natural, low-cost adjunct to standard post-extraction care to support faster tissue repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative adult patients willing to accept the study protocol
- •Minors with a cooperative parent/legal guardian providing consent
- •Non-surgical extraction of bilaterally positioned teeth
- •Low-to-moderate extraction difficulty per the Pederson scale
- •Systemically healthy, with no history of systemic disease
排除标准
- •Non-consenting patients
- •Failure to attend follow-up appointments per protocol
- •Heavy smokers (>10 pack-years)
- •Systemic disease (e.g., diabetes mellitus, immunosuppressive syndromes)
- •Current use of contraceptive medication
- •Systemic antibiotic therapy within the previous 3 months
- •Anticoagulant therapy within the previous 4 weeks
- •Requirement for antibiotic prophylaxis
- •Pregnant or breastfeeding women
- •Known allergy to honey or bee-related products
- •Known allergy to local anesthetics used in dental procedures
- •Higher-difficulty extractions requiring sutures or other hemostatic measures
研究组 & 干预措施
Contralateral extraction site treated with saline mouthwash only
干预措施: Saline rinse (control) (Other)
Extraction site treated with a propolis-based solution
干预措施: Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract) (Drug)
结局指标
主要结局
Percentage of Extraction Socket Surface Area Closure
时间窗: Baseline (Day 0), Day 7, and Day 14 post-extraction
Percentage reduction in socket surface area from baseline, calculated from 3D intraoral scans using the formula: % Closure = (Baseline area - Timepoint area) / Baseline area × 100.
次要结局
- Postoperative Pain Score(Day 1, Day 3, and Day 7 post-extraction)