Gingival Recession, Mucogingival Surgery
Conditions
Keywords
mucogingival surgery, recession, gingival graft, palatal donor site, medical grade manuka honey, healing, pain
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.
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
DEVICEPalatal 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.
DEVICEPalatal plate with Manuka Honey
A Palatal plate with Manuka Honey will be inserted by a blinded researcher on the donor site.
Sponsors
Nancy Mouradian
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Level | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Keratinized tissue width | ,Keratinized tissue width will be measured at 2, 6 and 12 months. | 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. |
| Landry Wound Index | It will be determined at 1, 2, 3, 4, 6 weeks, 2 months. | 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. |
| Other complications | Other complications will be assessed daily for 14 days | 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. |
| Root Coverage | Root coverage will be measured at 2, 6 and 12 months | 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. |
| Bubbling Test | It will be measured at 1, 2, 3, 4, 6 weeks, 2 months. | 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. |
Countries
Canada
Contacts
Primary ContactCamille Côté-Laroche, DMD, MSc (candidate)
Backup ContactMaya El Choueiri, Masters in Dental Sciences
Outcome results
None listed