- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482878
Tinder Fungus as an Adjunct to Non-surgical Periodontal Therapy for Periodontitis
Tinder Fungus (Fomes Fomentarius) as an Adjunct to Non-surgical Periodontal Therapy for Periodontitis: A Randomized Controlled Trial
The goal of this interventional clinical study is to learn if a Tinder fungus-based formulation -specifically a toothpaste and oral supplement powder-works as adjuncts to non-surgical periodontal therapy (NSPT) in patients with periodontitis.
The main questions it aims to answer is:
• Does the Tinder fungus-based formulation as an adjunct to NSPT reduce bleeding on probing more than a commercially available toothpaste as an adjunct to NSPT? Researchers will compare tinder fungus toothpaste and oral powder as an adjunct to NSPT to a commercially available toothpaste as an adjunct to NSPT to see if the Tinder fungus-based formulation works as adjuncts to NSPT in patients with periodontitis.
Participants will:
- Take tinder fungus toothpaste and oral powder or a commercially available toothpaste as an adjunct to NSPT twice daily for 30 consecutive days
- Visit the clinic at least twice including a visit before and after the intervention
- Keep a diary documenting their well-being and the number of times they used the toothpastes in the morning and evening.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vienna
-
Vienna, Vienna, Austria, 1020
- Dental Clinic of the Sigmund Freud Private University
-
Contact:
- Hady Haririan, Prof,Dr,PhD,MSc
- Phone Number: +4317201966
- Email: hady.haririan@med.sfu.ac.at
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Principal Investigator:
- Brenda Laky, PD,MSc,PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with Stage III or IV periodontitis
- Patients who have not yet initiated periodontal therapy
- Patients who have at least 20 remaining teeth
- Patients who are willing to use an electric toothbrush
- Patients who are willing to use interdental brushes
Exclusion Criteria:
- Patients who have previously received treatment for periodontitis
- Patients who have already undergone or initiated periodontal therapy
- Patients with a known allergy or intolerance to any component of the toothpaste or the powder
- Patients who are already using a product that contains tinder fungus (Fomes fomentarius)
- Patients who, at the time of periodontal treatment, are undergoing active systemic cancer therapy (e.g., chemotherapy or immunotherapy) or radiotherapy in the head and neck region, or for whom such therapy is planned. Previous illnesses or completed therapies do not constitute an exclusion criterion, provided that no current or planned treatment exists that could influence the periodontal treatment outcome or pose an increased risk for the participants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tinder fungus-based formulation (toothpaste and oral supplement powder)
Tinder fungus toothpaste plus oral supplement powder as adjuncts to non-surgical periodontal therapy (NSPT) in patients with periodontitis
|
Participants will receive Tinder fungus (Fomes fomentarius)-based formulations including a toothpaste plus an oral supplement powder as adjuncts to non-surgical periodontal therapy (NSPT).
|
|
Active Comparator: commercially available toothpaste
Commercially available toothpaste as adjuncts to non-surgical periodontal therapy (NSPT) in patients with periodontitis
|
A standard commercially available toothpaste administered as an adjunct to NSPT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bleeding on probing (BoP in %) change
Time Frame: changes from baseline (T0; 1 day before intervention starts) to reevaluation (T1; 5 weeks (±1 week) after intervention start)
|
Bleeding on probing (BoP in %) changes from baseline (T0) to reevaluation (T1).
BOP will be recorded as yes/no for each of 6 sites and reported as the percentage of affected sites per participant.
|
changes from baseline (T0; 1 day before intervention starts) to reevaluation (T1; 5 weeks (±1 week) after intervention start)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19113705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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