Role of Manuka Honey in Lowering Pain and Boosting Healing After Gum Graft Surgery.
NCT ID: NCT07016373
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
24 participants
INTERVENTIONAL
2025-06-20
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction
NCT06073639
MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting
NCT03728244
Evaluate the Effect of Graft and Membrane on Healing of Apicomarginal Defects
NCT04366700
Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting
NCT05819632
Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix
NCT04462237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Palatal plate with Manuka Honey
A Palatal plate with Manuka Honey will be inserted by a blinded researcher on the donor site.
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.
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.
Palatal plate with Manuka Honey
A Palatal plate with Manuka Honey will be inserted by a blinded researcher on the donor site.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Palatal plate with Manuka Honey
A Palatal plate with Manuka Honey will be inserted by a blinded researcher on the donor site.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nancy Mouradian
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nancy Mouradian
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP
Role: STUDY_DIRECTOR
Laval University
Benjamin Labelle, DMD, MSc, Cert. Perio, FRCD(C)
Role: STUDY_DIRECTOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Laval university- Faculty of Dentistry
Québec, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-471 / 28-11-2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.