Effect of Topical Application of Medical Grade Manuka Honey on Pain Intensity and Tissue Healing After Palatal Epithelial-connective Tissue Graft Harvesting: a Double-blinded Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Patient Pain Level
研究概览
简要总结
The goal of this clinical trial is to learn if medical grade Manuka Honey works to lower pain and improve healing sites after gum grafting surgery. The main questions are:
- Does medical grade Manuka honey lower pain and painkiller use after gum grafting surgery ?
- Does medical grade Manuka honey boost healing after gum grafting surgery ?
Researchers will compare, within the same patient, the results of a surgery with the application of Manuka honey in a retainer to a surgery without the application of honey in the retainer for the healing period.
Participants will:
- Visit the clinic for their first surgery.
- Fill up a daily survey to explain their level of pain and the amount of painkiller drugs used.
- Visit the clinic once every week for 6 weeks for follow-ups.
- Visit the clinic for their second surgery, four weeks after the first one.
- Fill up a daily survey to explain their level of pain and the amount of painkiller drugs used after the second surgery.
- Visit the clinic once every week for 6 weeks for follow-ups on the second surgery
- Fill a survey to compare both surgeries .
- Visit the clinic 2 months, 6 months and one year after the surgeries for more follow-ups.
详细描述
The study aims to identify if medical grade Manuka honey applied to the donor site has an impact on:
- postoperative pain using a visual analogue scale and by assessing patients' consumption of analgesics
- wound healing using the Landry Wound Healing Index and the hydrogen peroxide test which detects the level of epithelialisation of the wound (incomplete or complete).
During the preoperative phase, an initial periodontal assessment will be made to determine the eligibility of patients to participate in the study according to the inclusion and exclusion criteria. Depending on their needs, the 24 participants will receive supra and/or sub-gingival scaling at least four weeks prior to the first surgery. An alginate impression of the maxilla will be taken for all participants for the fabrication of the palatal plate.
Immediately prior to surgery, participants will gargle with a 0.12% chlorhexidine gluconate mouthwash for one minute and will receive a 600 mg ibuprofen tablet . They will be instructed to take another 600 mg ibuprofen tablet six hours later. Participants will receive two surgeries with a palatal harvest (one on each side of the palate). The recipient site will be prepared conventionally. During surgery, recipient sites will be distant from donor sites (mandibular recipient site and palatal donor site). A safety distance of 2 mm from the marginal gingiva should be maintained during incisions. Glandular and fatty tissue will be removed from the graft, which may or may not be de-epithelialized depending on the procedure for which it was harvested. It will then be adapted to the recipient site and sutured in place. The dimensions of the graft and of the wound at the donor site will be measured using a UNC 15 probe. Primary contraction can then be assessed. The residual thickness of the palatal tissue will also be assessed at this time, using a 30C anaesthetic needle, to which we will add a rubber stopper for an endodontic file. Measurement is then taken using an endodontic ruler.
For the healing period of one of the gingival grafts, the patient will wear a palatal plate with medical grade Manuka honey, and, for the other gingival graft, the patient will wear a palatal plate without a topical agent. A refractory period of at least four weeks will be observed between procedures. The palatal plate will be maintained for 7 days. A different clinician will insert and remove the palatal plate to preserve double blinding.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Participants must :
- •Be 18 years of age or older.
- •Be in good systemic health or have well-controlled systemic health.
- •Have a healthy or stable periodontium after conventional periodontal treatment.
- •Have good clinical gingival health or gingivitis on an intact or reduced periodontium, with or without a history of periodontitis
- •Maintain good oral hygiene.
- •Have a simplified plaque index and gingival bleeding index below 20%
- •Require two mucogingival surgeries involving bilateral epithelial-conjunctival graft harvesting (free gingival graft or de-epithelialised connective tissue graft).
- •The surgeries must treat single or multiple gingival recessions, or mucogingival defects around teeth or implants.
排除标准
- •Smokers or users of other tobacco products
- •Pregnant participants
- •Participants who are uncooperative or have a psychological condition that makes free and informed consent or compliance with instructions impossible
- •Participants with a condition that impairs healing (e.g. poorly controlled diabetes, coagulation disorder, etc.) or the objective assessment of pain at the sampling site (e.g. autoimmune diseases, orofacial pain, etc.)
- •Participants regularly taking the following medications : non-steroidal anti-inflammatory drugs, bisphosphonates, sedatives, psychotropic drugs and corticosteroids.
- •During the study, those who develop a condition that interferes with healing, become smokers, start medication that acts on the central nervous system, do not adhere strictly to instructions or do not respect follow-ups.
- •Participants who have already received a palatal surgery in the past or whose palatal tissue thickness is less than 3 mm will not be excluded, to allow comparative analyses in sub-groups.
研究组 & 干预措施
Surgery A with Honey/ Surgery B without Honey
Surgeries A and B will be performed 4 weeks apart. During both surgeries, recipient sites will be distant from donor sites (mandibular recipient site and palatal donor site). A safety distance of 2 mm from the marginal gingiva should be maintained during incisions. Glandular and fatty tissue will be removed from the graft, which may or may not be de-epithelialized depending on the procedure for which it was harvested. It will then be adapted to the recipient site and sutured in place. During post-operative healing, surgery A will include a palatal plate with Manuka honey . Surgery B will include a palatal plate without Manuka Honey.
干预措施: Palatal Plate without Manuka Honey (Device)
Surgery A with Honey/ Surgery B without Honey
Surgeries A and B will be performed 4 weeks apart. During both surgeries, recipient sites will be distant from donor sites (mandibular recipient site and palatal donor site). A safety distance of 2 mm from the marginal gingiva should be maintained during incisions. Glandular and fatty tissue will be removed from the graft, which may or may not be de-epithelialized depending on the procedure for which it was harvested. It will then be adapted to the recipient site and sutured in place. During post-operative healing, surgery A will include a palatal plate with Manuka honey . Surgery B will include a palatal plate without Manuka Honey.
干预措施: Palatal plate with Manuka Honey (Device)
Surgery A without Honey/ Surgery B with Honey
Surgeries A and B will be performed 4 weeks apart. During both surgeries, recipient sites will be distant from donor sites (mandibular recipient site and palatal donor site). A safety distance of 2 mm from the marginal gingiva should be maintained during incisions. Glandular and fatty tissue will be removed from the graft, which may or may not be de-epithelialized depending on the procedure for which it was harvested. It will then be adapted to the recipient site and sutured in place. During post-operative healing, surgery A will include a palatal plate without Manuka honey . Surgery B will include a palatal plate with Manuka Honey.
干预措施: Palatal Plate without Manuka Honey (Device)
Surgery A without Honey/ Surgery B with Honey
Surgeries A and B will be performed 4 weeks apart. During both surgeries, recipient sites will be distant from donor sites (mandibular recipient site and palatal donor site). A safety distance of 2 mm from the marginal gingiva should be maintained during incisions. Glandular and fatty tissue will be removed from the graft, which may or may not be de-epithelialized depending on the procedure for which it was harvested. It will then be adapted to the recipient site and sutured in place. During post-operative healing, surgery A will include a palatal plate without Manuka honey . Surgery B will include a palatal plate with Manuka Honey.
干预措施: Palatal plate with Manuka Honey (Device)
结局指标
主要结局
Patient Pain Level
时间窗: Pain levels will be assessed daily for 14 days
Patient's percieved pain levels will be measured daily at the exact same hour for 14 days with a survey, where they will indicate: Their pain levels with a visual analog scale ranging from 0 to 10. 0 indicates no pain and 10 indicates the maximum pain imaginable.
Daily Ibuprofen Intake
时间窗: Pain levels will be assessed daily for 14 days
Patient's ibuprofen intake will be declared daily at the exact same hour for 14 days with a survey, where they will indicate The daily intake of ibuprofen tablets (n of tablets taken during the day)
次要结局
- Landry Wound Index(It will be determined at 1, 2, 3, 4, 6 weeks, 2 months.)
- Bubbling Test(It will be measured at 1, 2, 3, 4, 6 weeks, 2 months.)
- Keratinized tissue width(,Keratinized tissue width will be measured at 2, 6 and 12 months.)
- Root Coverage(Root coverage will be measured at 2, 6 and 12 months)
- Other complications(Other complications will be assessed daily for 14 days)
研究者
Nancy Mouradian
Clinical Professor
Laval University