Gingival Recession, Mucogingival SurgeryPhase 2NCT07016373
Role of Manuka Honey in Lowering Pain and Boosting Healing After Gum Graft Surgery.
A Phase 2 study testing Palatal Plate without Manuka Honey and Palatal plate with Manuka Honey in people with Gingival Recession, Mucogingival Surgery, run by Nancy Mouradian at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Mucogingival Surgery
- What is being tested?
- Palatal Plate without Manuka Honey and Palatal plate with Manuka Honey
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2025to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Laval university- Faculty of Dentistry
Québec, Quebec, G1V 0A6
Camille Côté-Laroche, DMD. MSc (candidate), 819-806-4806, camille.cote-laroche.1@ulaval.ca
Maya El Choueiri, MSc in Dental Sciences, 4389283316, maya.choueiry.1@ulaval.ca
About this study
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
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 ?
Read more
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.
Read the 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.
- Conditions
- Gingival Recession, Mucogingival Surgery
- Being tested
- Palatal Plate without Manuka Honey, Palatal plate with Manuka Honey
- Keywords
- mucogingival surgery, recession, gingival graft, palatal donor site, medical grade manuka honey, healing, pain
- Medical subject headings
- Gingival Recession, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal Plate without Manuka HoneyDevice
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 HoneyDevice
A Palatal plate with Manuka Honey will be inserted by a blinded researcher on the donor site.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Palatal Plate without Manuka Honey; Device: Palatal plate with Manuka Honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Pain levels will be assessed daily for 14 days
Secondary outcomes (5)
Landry Wound Index
Palatal wound healing will be evaluated by the clinician himself using the Landry Wound Healing Index, an index that tests healing with specific criteria like tissue color, palpation response, incision margin and the extent of the wound. This index is a scale from 1 to 5 where 1 is very poor healing and 5 is excellent healing.
Measured: It will be determined at 1, 2, 3, 4, 6 weeks, 2 months.
Bubbling Test
Palatal wound healing will also be evaluated by the clinician himself using the Bubbling test that uses hydrogen peroxide at 3% to determine if the tissue re-epithelialized completely. The presence of bubbles indicates that the wound did not epithelialize completely yet. Absence of bubbles indicates complete epithelialization. This will be measured dichotomously with 0 being incomplete epithelialization and 1 being complete epithelialization.
Measured: It will be measured at 1, 2, 3, 4, 6 weeks, 2 months.
Keratinized tissue width
Keratinized tissue width (in mm) and will be assessed at 2, 6 and 12 months. It is typically measured from the gingival margin to the mucogingival junction using a periodontal probe.
Measured: ,Keratinized tissue width will be measured at 2, 6 and 12 months.
Root Coverage
Root coverage (in %) will be assessed at 2, 6 and 12 months. We will initially measure the depth of recession (in mm), and will do so at the designated time frames. The difference between initial and follow-up measures will then be reported as a percentage of the initial measurement.
Measured: Root coverage will be measured at 2, 6 and 12 months
Other complications
The other complications will be part of the pain level survey that will be filled by patients, where they will indicate if they feel any other sort of complications. It will be a qualitative outcome to bring more accuracy to patients' experience with the treatment.
Measured: Other complications will be assessed daily for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start20 Jun 2025 (estimated)
- Primary completion26 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, Mucogingival SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a split-mouth model where the patient will be their own control, receiving two surgeries but with different post-operative care.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nancy Mouradian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nancy Mouradian, Laval University
- Investigators
- Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP, Study director, Laval UniversityBenjamin Labelle, DMD, MSc, Cert. Perio, FRCD(C), Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016373
- Sponsor's protocol ID
- 2024-471 / 28-11-2024
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30304077Wessel 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.
PubMed 18315424Del 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.
PubMed 12423299Rajapakse 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.
PubMed 17953693Lost 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.
PubMed 6593330Serino 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.
PubMed 8126246Kennedy 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.
PubMed 3902907Wennstrom 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.
PubMed 3470324Cortellini 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.
PubMed 29926948Chambrone 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.
PubMed 26878749Romandini 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.
PubMed 32748539Kassab 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.
PubMed 12636127Albandar 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.
PubMed 10052768Lava-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.
PubMed 1152058Agossa 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.
PubMed 28865819
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07016373
- Acronym / sponsor ID
- 2024-471 / 28-11-2024
- Conditions
- Gingival Recession, Mucogingival Surgery
- Keywords
- mucogingival surgery, recession, gingival graft, palatal donor site, medical grade manuka honey, healing, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nancy MouradianUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a split-mouth model where the patient will be their own control, receiving two surgeries but with different post-operative care.
| Arm | Type | Receives |
|---|---|---|
| Surgery A with Honey/ Surgery B without Honey | Experimental | Device: Palatal Plate without Manuka Honey, Device: Palatal plate with Manuka HoneySurgeries 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. |
| Surgery A without Honey/ Surgery B with Honey | Experimental | Device: Palatal Plate without Manuka Honey, Device: Palatal plate with Manuka HoneySurgeries 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palatal Plate without Manuka HoneyA Palatal plate without Manuka Honey will be inserted by a blinded investigator on the donor site for post-operative procedures. | Device | Surgery A with Honey/ Surgery B without Honey, Surgery A without Honey/ Surgery B with Honey |
| Palatal plate with Manuka HoneyA Palatal plate with Manuka Honey will be inserted by a blinded researcher on the donor site. | Device | Surgery A with Honey/ Surgery B without Honey, Surgery A without Honey/ Surgery B with Honey |
Primary outcome
Patient Pain Level
Time frame: 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
Time frame: 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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 30304077Tavelli 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.
- Background: PubMed 18315424Wessel 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.
- Background: PubMed 12423299Del 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.
- Background: PubMed 17953693Rajapakse 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.
- Background: PubMed 6593330Lost 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.
- Background: PubMed 8126246Serino 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.
- Background: PubMed 3902907Kennedy 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.
- Background: PubMed 3470324Wennstrom 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.
- Background: PubMed 29926948Cortellini 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.
- Background: PubMed 26878749Chambrone 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.
- Background: PubMed 32748539Romandini 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.
- Background: PubMed 12636127Kassab 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP study director
Laval University
Benjamin Labelle, DMD, MSc, Cert. Perio, FRCD(C) study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palatal Plate without Manuka Honey and Palatal plate with Manuka Honey in people with Gingival Recession, Mucogingival Surgery, run by Nancy Mouradian at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille Côté-Laroche, DMD, MSc (candidate) (819-806-4806, camille.cote-laroche.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Pain Level (time frame: Pain levels will be assessed daily for 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07016373, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.