Theranovis Dental Gel in Patients With Gingivitis
The Effects of Theranovis Dental Gel in Patients With Gingivitis: A Prospective Pilot Study
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of this randomized, blinded, controlled study is to compare the theranovis dental gel with a placebo product in order to determine whether an improvement in oral health can be achieved in patients with gingivitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
June 11, 2026
June 1, 2026
10 months
May 26, 2026
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BOP - bleeding on probing
Change in Bleeding on Probing (BOP) percentage
8 weeks
Secondary Outcomes (2)
PI - Plaque Index
8 weeks
PBI - Papillary bleeding index
8 weeks
Study Arms (2)
theranovis dental gel group
ACTIVE COMPARATORTen participants will receive the theranovis dental gel
Placebo group
PLACEBO COMPARATORTen participants will receive the placebo product
Interventions
The dental gel should be applied with a manual toothbrush every morning and evening after toothbrushing, left in place for 30 seconds without swallowing, and then spat out without rinsing with water afterward.
The dental gel should be applied with a manual toothbrush every morning and evening after toothbrushing, left in place for 30 seconds without swallowing, and then spat out without rinsing with water afterward.
Eligibility Criteria
You may qualify if:
- Male and female participants aged over 18 years
- At least 12 teeth per jaw (natural teeth, including restorations such as crowns and implants)
- Smokers (less than 10 cigarettes per day)
- Gingivitis with intact periodontium (probing depth ≤ 3.0 mm, bleeding on probing \> 10%)
- Gingivitis with intact periodontium (probing depth ≤ 4 mm, no bleeding on probing at these sites)
- Periodontal screening index (PSI) up to grade 2
You may not qualify if:
- Male and female participants under 18 years of age
- Fewer than 12 teeth per jaw
- Individuals not capable of giving informed consent
- Individuals with hypersensitivity or allergies to any of the study product ingredients
- Patients with periodontitis
- Patients with non-plaque-induced gingivitis
- Periodontal screening index (PSI) grade 3 or higher
- Current antibiotic prophylaxis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinik für Zahnmedizin und Mundgesundheit
Graz, Styria, 8010, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2026
First Posted
June 11, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
The data will be used exclusively for the conduct of the diploma thesis study.