Effect of Antimicrobial Gel With Postbiotics, Lactoferrin, Aloe Barbadensis Leaf Juice Powder and Sodium Hyaluronate on Palatal Mucosa Wound Healing: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Color Match (CM)
研究概览
简要总结
The present study will be a prospective, randomized, triple-blind, split-mouth, clinical trial.
The study timeline will be include seven total visits. After a screening/study enrolment visit, a wounding surgery visit (Day 0) will be schedule. On Day 0, one standardized wound will be created on each side of the palate (DFGG required for root coverage procedure). Each side of the palate randomly received either antimicrobial gel (treatment group) or placebo (control group) at day 0, 1 and 3.
The patients, an experienced periodontist who performed the surgical procedures and the clinical examiners will be blinded to treatment allocation.
Clinical healing response and patient related outcome measures (PROMs) will be evaluated on postoperative Day 1, 3, 7, 14, 21 and 30.
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
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 38 years (age limits based on evidence of delayed wound healing in older adults, Engeland et al., 2006);
- •full-mouth plaque score and full-mouth bleeding score ≤ 15% at study entry;
- •adequate anteroposterior arch length for required wound size and spacing;
- •able to easily tolerate maxillary impression making and use of palatal template;
- •patients required at least two root coverages procedures in one tooth in different sextants with DFGG;
- •palate with no pathological or morphological alteration.
排除标准
- •untreated periodontitis;
- •previous surgery on the palate;
- •history of poor wound healing;
- •systemic diseases and/or coagulations disorders;
- •pregnant or lactating;
- •smoking or marijuana use (non-smoker status verified by exhaled air carbon monoxide as previously described);
- •medications affecting periodontal status (e.g. phenytoin, calcium channel blockers and cyclosporine);
- •therapy with anticoagulants, nonsteroidal anti-inflammatory drugs, corticosteroids, or any drug interfering with the healing process during the previous six months;
- •contraindication to receiving any of the active components of the antimicrobial gel.
结局指标
主要结局
Color Match (CM)
时间窗: CM will be evaluated on post-operative days 1, 3, 7, 14, 21 and 30
CM will be evaluated comparing color of the adjacent and opposite sides again using VAS scores from 0 (no CM) to 10 (excellent CM)
次要结局
- Healing Index (HI)(HI will be assessed on post-operative days 1, 3, 7, 14, 21 and 30)
- Secondary Healing Classification (SHC)(SHC will be assessed on post-operative days 1, 3, 7, 14, 21 and 30)
- Complete epithelization (CE)(CE will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.)
- Oral Health Impact Profile-14 (OHIP-14)(It will be evaluated at baseline and on post-operative days 1, 3, 7, 14, 21 and 30)
- Functional Pain Scale (FPS)(It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.)
- Swelling(It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.)
- Burning sensation(It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.)
- Discomfort(It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.)
研究者
Andrea Pilloni MD DDS MS
Principal Investigator
University of Roma La Sapienza