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

NCT07016373 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2024-471 / 28-11-2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession, Mucogingival Surgery

Keywords

mucogingival surgery; recession; gingival graft; palatal donor site; medical grade manuka honey; healing; pain

Outcome Measures

Primary Outcomes (2)

• Patient Pain Level

  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.

  Pain levels will be assessed daily for 14 days

• Daily Ibuprofen Intake

  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)

  Pain levels will be assessed daily for 14 days

Secondary Outcomes (5)

• 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

Study Arms (2)

Surgery A with Honey/ Surgery B without Honey

EXPERIMENTAL

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.

Device: Palatal Plate without Manuka Honey; Device: Palatal plate with Manuka Honey

Surgery A without Honey/ Surgery B with Honey

EXPERIMENTAL

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.

Device: Palatal Plate without Manuka Honey; Device: Palatal plate with Manuka Honey

Interventions

Palatal Plate without Manuka Honey DEVICE

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

Surgery A with Honey/ Surgery B without Honey; Surgery A without Honey/ Surgery B with Honey

Palatal plate with Manuka Honey DEVICE

A Palatal plate with Manuka Honey will be inserted by a blinded researcher on the donor site.

Surgery A with Honey/ Surgery B without Honey; Surgery A without Honey/ Surgery B with Honey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nancy Mouradian: lead

Study Sites (1)

Laval university- Faculty of Dentistry

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (19)

• 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.

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• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cortellini P, Bissada NF. Mucogingival conditions in the natural dentition: Narrative review, case definitions, and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S204-S213. doi: 10.1002/JPER.16-0671.

  PMID: 29926948 BACKGROUND

• Chambrone L, Tatakis DN. Long-Term Outcomes of Untreated Buccal Gingival Recessions: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Jul;87(7):796-808. doi: 10.1902/jop.2016.150625. Epub 2016 Feb 15.

  PMID: 26878749 BACKGROUND

• Romandini M, Soldini MC, Montero E, Sanz M. Epidemiology of mid-buccal gingival recessions in NHANES according to the 2018 World Workshop Classification System. J Clin Periodontol. 2020 Oct;47(10):1180-1190. doi: 10.1111/jcpe.13353. Epub 2020 Sep 2.

  PMID: 32748539 BACKGROUND

• Kassab MM, Cohen RE. The etiology and prevalence of gingival recession. J Am Dent Assoc. 2003 Feb;134(2):220-5. doi: 10.14219/jada.archive.2003.0137.

  PMID: 12636127 BACKGROUND

• Albandar JM, Kingman A. Gingival recession, gingival bleeding, and dental calculus in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):30-43. doi: 10.1902/jop.1999.70.1.30.

  PMID: 10052768 BACKGROUND

• Lava-Sanchez PA, Puppo S. Occurrence in vivo of "hidden breaks" at specific sites of 26 S ribosomal RNA of Musca carnaria. J Mol Biol. 1975 Jun 15;95(1):9-20. doi: 10.1016/0022-2836(75)90331-9. No abstract available.

  PMID: 1152058 BACKGROUND

• Agossa K, Godel G, Dubar M, S Y K, Behin P, Delcourt-Debruyne E. Does Evidence Support a Combined Restorative Surgical Approach for the Treatment of Gingival Recessions Associated With Noncarious Cervical Lesions? J Evid Based Dent Pract. 2017 Sep;17(3):226-238. doi: 10.1016/j.jebdp.2017.04.001. Epub 2017 Apr 11.

  PMID: 28865819 BACKGROUND

• Yupanqui Mieles J, Vyas C, Aslan E, Humphreys G, Diver C, Bartolo P. Honey: An Advanced Antimicrobial and Wound Healing Biomaterial for Tissue Engineering Applications. Pharmaceutics. 2022 Aug 10;14(8):1663. doi: 10.3390/pharmaceutics14081663.

  PMID: 36015289 BACKGROUND

• Tavelli L, Barootchi S, Stefanini M, Zucchelli G, Giannobile WV, Wang HL. Wound healing dynamics, morbidity, and complications of palatal soft-tissue harvesting. Periodontol 2000. 2023 Jun;92(1):90-119. doi: 10.1111/prd.12466. Epub 2022 Dec 30.

  PMID: 36583690 BACKGROUND

• Carter DA, Blair SE, Cokcetin NN, Bouzo D, Brooks P, Schothauer R, Harry EJ. Therapeutic Manuka Honey: No Longer So Alternative. Front Microbiol. 2016 Apr 20;7:569. doi: 10.3389/fmicb.2016.00569. eCollection 2016.

  PMID: 27148246 BACKGROUND

• Alasqah M, Alrashidi A, Alshammari N, Alshehri A, Gufran K. Effect of honey dressing material on palatal wound healing after harvesting a free gingival graft: a prospective randomized case control study. Eur Rev Med Pharmacol Sci. 2022 Apr;26(8):2662-2668. doi: 10.26355/eurrev_202204_28595.

  PMID: 35503610 BACKGROUND

MeSH Terms

Conditions

Gingival Recession; Pain

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP

  Laval University

  STUDY DIRECTOR

• Benjamin Labelle, DMD, MSc, Cert. Perio, FRCD(C)

  STUDY DIRECTOR

Central Study Contacts

Camille Côté-Laroche, DMD, MSc (candidate)

CONTACT

819-806-4806; camille.cote-laroche.1@ulaval.ca

Maya El Choueiri, Masters in Dental Sciences

CONTACT

4389283316; maya.choueiry.1@ulaval.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a split-mouth model where the patient will be their own control, receiving two surgeries but with different post-operative care.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 11, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

CA (1)