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

Nancy Mouradian

Status and phase: Not yet enrolling; Phase 2

Conditions: Gingival Recession, Mucogingival Surgery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07016373

2024-471 / 28-11-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Surgery A with Honey/ Surgery B without Honey

Experimental group

Description:

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.

Treatment:

Device: Palatal Plate without Manuka Honey

Device: Palatal plate with Manuka Honey

Surgery A without Honey/ Surgery B with Honey

Experimental group

Description:

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.

Treatment:

Device: Palatal Plate without Manuka Honey

Device: Palatal plate with Manuka Honey