Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- pain / discomfort (burning) perception by means of a 100 mm VAS
研究概览
简要总结
Establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff around teeth/implants is considered of importance for long-term stability. This can more readily be achieved by means of autogenous soft tissue grafts harvested from the palate than with soft tissue substitutes. However, this often implies the creation of an open palatal wound involving secondary intention healing. The aim of this randomized controlled, split-mouth, clinical trial is to assess the effect of a hyaluronic acid containing commercial product on wound healing and patient morbidity after palatal soft tissue harvesting. Altogether, 20 volunteers will be recruited. An individualized splint containing 2 symmetrically located contralateral cylindrical openings will be used for standardized soft tissue harvesting (6 mm in Ø, 2 mm in depth). Soft tissue grafts will be harvested randomly from the right or left side and patients will be monitored for 3 weeks followed by a 1-month wash-out period prior to harvesting the second soft tissue graft from the other side. Participants will randomly start treating the palatal wound either with the test product (GUM Aftaclear Gel, Sunstar Suisse SA, Etoy, Switzerland; 0.3%) or saline solution for 7 days to promote the healing process, which will be reversed for the second round. Patient-related outcomes (morbidity, discomfort, taste alteration, pain killer consumption), frequency of bleeding events, defect closure (area, volume), and microbial colonisation will be recorded and analysed for any differences between the control and test product. Further, in 6 additional volunteers, biopsies of the healing wound are collected in a similar fashion as described above, but with the use of a larger stent in order to harvest also pristine surrounding tissues for histological analysis; biopsies are collected up to 14 days of healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years,
- •systemically healthy,
- •healthy periodontal conditions at the experimental region or conditions not interfering with proper biopsy harvesting,
- •no known sensitivity to HY,
- •no uncontrolled diabetes mellitus,
- •no radiotherapy or chemotherapy,
- •no current pregnancy or breastfeeding,
- •no hormonal diseases,
- •no infectious diseases,
- •no autoimmune diseases or under immunotherapy,
- •no systemic bone disease,
- •no wound healing disorders or acute inflammatory/infectious processes,
- •no systemic diseases with implications on mucous membranes (e.g., Morbus Crohn),
- •no increased risk of bleeding (i.e., patient with coagulation disorders or under anticoagulant therapy, and
- •no heavy smokers (i.e., no regular tobacco consumption > 10 cigarettes/day).
排除标准
- •not meeting the inclusion criteria.
结局指标
主要结局
pain / discomfort (burning) perception by means of a 100 mm VAS
时间窗: 21 days
0 indicates no pain, 100 indicates maximum pain
次要结局
- pain killer consumption(21 days)
- frequency of re-bleeding(21 days)
- changes in total and specific bacterial counts(14 days)
- defect volume fill by overlay of the intraoral scans(21 days)
- food restrictions (yes/no)(21 days)
- taste alteration experience by means of a 100 mm VAS(21 days)
- disturbance while eating or drinking by means of a 100 mm VAS(21 days)
- re-epithelialised defect area (by means of standardized photographs)(21 days)
- re-epithelisation by colorimetric digital assessment of the calibrated photographs(21 days)
研究者
Andreas Stavropoulos
Prof
Malmö University