Manuka Honey for Receding Gums

Overseen By Camille Côté-Laroche, DMD, MSc (candidate)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nancy Mouradian

Must not be taking: NSAIDs, Bisphosphonates, Sedatives, others

Disqualifiers: Smokers, Pregnant, Poorly controlled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether medical-grade Manuka honey can reduce pain and speed up healing after gum grafting surgery. Participants will undergo two surgeries: one with Manuka honey in a retainer and one without. Researchers seek individuals who have received conventional periodontal treatment, maintain good oral hygiene, and require two gum graft surgeries. The study includes regular clinic visits and daily surveys about pain and painkiller use. Participants must not smoke or use tobacco and should not have conditions that impair healing. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative dental care solutions.

Do I have to stop taking my current medications for the trial?

If you regularly take non-steroidal anti-inflammatory drugs, bisphosphonates, sedatives, psychotropic drugs, or corticosteroids, you cannot participate in the trial. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Manuka honey could be a safe treatment option. Studies have found that it fights bacteria and reduces inflammation, benefiting dental health. In past studies, Manuka honey treated gum inflammation and was well-tolerated by patients without serious side effects. It has also been used alongside other treatments to improve gum health and was found to be safe in these cases as well.

Since this trial is in Phase 2, Manuka honey has already passed initial safety tests. This phase evaluates how well the treatment is tolerated by a larger group of people. While there are no guarantees, existing evidence suggests that Manuka honey is safe for human use, particularly for dental care. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using Manuka honey for receding gums because it offers a natural approach to healing that differs from standard treatments like scaling and root planing or graft surgeries. Manuka honey is known for its antimicrobial properties, which can help reduce bacterial infections and promote healing in gum tissues. Unlike traditional methods that primarily focus on mechanical removal of plaque or tissue grafting, the honey acts as a soothing and protective agent during post-operative recovery. This unique mechanism of action could enhance healing outcomes and comfort for patients undergoing gum surgery.

What evidence suggests that Manuka Honey might be an effective treatment for receding gums?

Research has shown that Manuka honey can help with oral health problems. Studies have found that it fights bacteria in the mouth and reduces plaque and gum inflammation. One study found that people who chewed Manuka honey strips daily had less plaque and fewer bleeding gums. Another study showed a significant drop in plaque levels, indicating that Manuka honey can improve oral health. In this trial, participants will undergo two surgeries: one with Manuka honey and one without. These results suggest that Manuka honey might reduce pain and aid healing after gum surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP

Principal Investigator

Laval University

Benjamin Labelle, DMD, MSc, Cert. Perio, FRCD(C)

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for individuals with receding gums who are undergoing gum graft surgery. Participants must be willing to attend multiple clinic visits, including follow-ups and two surgeries, and complete daily surveys about their pain levels and painkiller usage.

Inclusion Criteria

I am 18 years old or older.

My gums are healthy or stable after standard gum treatment.

My overall health is good or any health issues I have are well-managed.

Exclusion Criteria

Pregnant participants

Participants who are smokers or users of other tobacco products

Participants who are uncooperative or have a psychological condition that makes free and informed consent or compliance with instructions impossible

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Preoperative

Initial periodontal assessment and preparation for surgery, including scaling and alginate impression

4 weeks

1 visit (in-person)

Surgery and Initial Healing

Participants undergo two surgeries with a 4-week refractory period between them. Healing with and without Manuka honey is compared.

14 weeks

Weekly visits for 6 weeks post each surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of keratinized tissue width and root coverage.

12 months

Visits at 2, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Manuka Honey

Trial Overview The study aims to determine if medical grade Manuka honey can reduce pain and enhance healing after gum graft surgery. It involves comparing the effects of a palatal plate with Manuka honey versus one without it in the same patient across two separate surgeries.

How Is the Trial Designed?

Group I: Surgery A without Honey/ Surgery B with Honey Experimental Treatment 2 Interventions

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.

Group II: Surgery A with Honey/ Surgery B without Honey Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Nancy Mouradian

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9921343/

Therapeutic Manuka Honey as an Adjunct to Non-Surgical ... Despite the improvement in outcomes appearing modest in absolute terms, it was statistically significant for all follow-up time points, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5368358/

Periodontal Application of Manuka Honey: Antimicrobial ... [26] reported reduced plaque accumulation and gingival bleeding among human participants with gingivitis after chewing manuka honey strips for ten minutes daily ...

3. adum.um.edu.my adum.um.edu.my/index.php/adum/article/download/44356/16498/129669

Manuka Honey as an Adjunct to Nonsurgical Periodontal ... Adjunctive application of manuka honey to periodontal pockets improved gingival inflammation but did not demonstrate significant clinical ...

4. newzealandhoneyco.com newzealandhoneyco.com/blogs/honey-articles/manuka-honey-for-teeth?srsltid=AfmBOoq-a3DdN62OoCUqMDVCOGkyShTzOfiBqeCZQqACtXq41XLfwKJi

Manuka Honey for Teeth and Oral Health: Friend or Foe? This 2017 study showed that Manuka honey is effective in fighting certain oral bacteria, and this study from 2014 found Manuka honey to be a ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15125017/

The effects of manuka honey on plaque and gingivitis Analysis of the results indicated that there were statistically highly significant reductions in the mean plaque scores (0.99 reduced to 0.65; p=0.001), and the ...

6. researchgate.net researchgate.net/publication/367980433_Therapeutic_Manuka_Honey_as_an_Adjunct_to_Non-Surgical_Periodontal_Therapy_A_12-Month_Follow-Up_Split-Mouth_Pilot_Study

Therapeutic Manuka Honey as an Adjunct to Non-Surgical ... Plaque index (PI), bleeding on probing, gingival recession (GR), clinical attachment level (CAL), and PD were measured at baseline, at 6 ...

7. newzealandhoneyco.com newzealandhoneyco.com/blogs/honey-articles/manuka-honey-for-teeth?srsltid=AfmBOooSFuSggeaflzNg6BY7Rx1UDa6B2LTHtoRz7vqIpu59GfmpDwEZ

Manuka Honey for Teeth and Oral Health: Friend or Foe? Manuka honey has potent levels of antibacterial and anti-inflammatory properties which can help manage symptoms associated with the most common ...