Health TrialsbyHealthPanel

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

ConditionGingival Recession, Mucogingival Surgery
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNancy Mouradian

About this 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 ?

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • Palatal plate with Manuka Honey

    Device

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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Surgery A with Honey/ Surgery B without HoneyExperimental treatment 2 interventions
Group B: Surgery A without Honey/ Surgery B with HoneyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Pain levels will be assessed daily for 14 days
2

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)

Time frame
Pain levels will be assessed daily for 14 days

Secondary outcomes

1

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.

Time frame
It will be determined at 1, 2, 3, 4, 6 weeks, 2 months.
2

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.

Time frame
It will be measured at 1, 2, 3, 4, 6 weeks, 2 months.
3

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.

Time frame
,Keratinized tissue width will be measured at 2, 6 and 12 months.
4

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.

Time frame
Root coverage will be measured at 2, 6 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nancy Mouradian

Lead sponsor

Laval University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: