Role of Manuka Honey in Lowering Pain and Boosting Healing After Gum Graft Surgery.

Official title

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

Overview

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.

Detailed description

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.

The usual post-operative instructions for mucogingival surgery will be given verbally and in leaflet form to the participant. A prescription for ibuprofen and chlorhexidine gluconate 0.12% mouthwash will be given to the patient.

Participants will be required to complete the roadmap provided for 14 days following each intervention. Clinical follow-ups will take place at 1, 2, 3, 4 and 6 weeks and at 2, 6 and 12 months post-operatively. We will also measure the dimensions of the palatal wound at these follow-ups. At 2, 6 and 12 months, we will measure the width of keratinised tissue and root coverage obtained.

Interventions

• Device Palatal Plate without Manuka Honey
  A Palatal plate without Manuka Honey will be inserted by a blinded investigator on the donor site for post-operative procedures.
• Device Palatal plate with Manuka Honey
  A Palatal plate with Manuka Honey will be inserted by a blinded researcher on the donor site.

Primary outcome measures

• Patient Pain Level [Time frame: Pain levels will be assessed daily for 14 days]
• Daily Ibuprofen Intake [Time frame: Pain levels will be assessed daily for 14 days]

Secondary outcome measures (5)

• Landry Wound Index [Time frame: It will be determined at 1, 2, 3, 4, 6 weeks, 2 months.]
• Bubbling Test [Time frame: It will be measured at 1, 2, 3, 4, 6 weeks, 2 months.]
• Keratinized tissue width [Time frame: ,Keratinized tissue width will be measured at 2, 6 and 12 months.]
• Root Coverage [Time frame: Root coverage will be measured at 2, 6 and 12 months]
• Other complications [Time frame: Other complications will be assessed daily for 14 days]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• Laval university- Faculty of Dentistry — Québec

Publications

• Tavelli L, Asa'ad F, Acunzo R, Pagni G, Consonni D, Rasperini G. Minimizing Patient Morbidity Following Palatal Gingival Harvesting: A Randomized Controlled Clinical Study. Int J Periodontics Restorative Dent. 2018 Nov/Dec;38(6):e127-e134. doi: 10.11607/prd.3581. PMID 30304077
• Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325. PMID 18315424
• Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x. PMID 12423299
• Rajapakse PS, McCracken GI, Gwynnett E, Steen ND, Guentsch A, Heasman PA. Does tooth brushing influence the development and progression of non-inflammatory gingival recession? A systematic review. J Clin Periodontol. 2007 Dec;34(12):1046-61. doi: 10.1111/j.1600-051X.2007.01149.x. Epub 2007 Oct 22. PMID 17953693
• Lost C. Depth of alveolar bone dehiscences in relation to gingival recessions. J Clin Periodontol. 1984 Oct;11(9):583-9. doi: 10.1111/j.1600-051x.1984.tb00911.x. PMID 6593330
• Serino G, Wennstrom JL, Lindhe J, Eneroth L. The prevalence and distribution of gingival recession in subjects with a high standard of oral hygiene. J Clin Periodontol. 1994 Jan;21(1):57-63. doi: 10.1111/j.1600-051x.1994.tb00278.x. PMID 8126246
• Kennedy JE, Bird WC, Palcanis KG, Dorfman HS. A longitudinal evaluation of varying widths of attached gingiva. J Clin Periodontol. 1985 Sep;12(8):667-75. doi: 10.1111/j.1600-051x.1985.tb00938.x. PMID 3902907
• Wennstrom JL. Lack of association between width of attached gingiva and development of soft tissue recession. A 5-year longitudinal study. J Clin Periodontol. 1987 Mar;14(3):181-4. doi: 10.1111/j.1600-051x.1987.tb00964.x. PMID 3470324

Identifiers

NCT: NCT07016373 · 2024-471 / 28-11-2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗