Theranovis Dental Gel in Patients With Gingivitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: theranovis dental gel group, Placebo group.
- Who it may be relevant to
- Registry conditions: Gingivitis, Oral Health Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of Theranovis Dental Gel in Patients With Gingivitis: A Prospective Pilot Study
Overview
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.
Detailed description
This study will be conducted at the Medical University of Graz and will include a total of 20 participants, divided into two groups (10 participants per group). One group will receive theranovis dental gel, while the other group will receive a placebo product. Participants will be randomly assigned to the groups using a randomization list created before the start of the study.
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.
Participation in the study is expected to last 8 weeks. Study-related procedures include a professional dental cleaning at baseline, assessment of baseline values and repeated measurements of these parameters every 2 weeks during the study.
Interventions
- Other theranovis dental gel group
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. - Other Placebo group
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.
Primary outcome measures
- BOP - bleeding on probing [Time frame: 8 weeks]
Secondary outcome measures (2)
- PI - Plaque Index [Time frame: 8 weeks]
- PBI - Papillary bleeding index [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Universitätsklinik für Zahnmedizin und Mundgesundheit — Graz
Identifiers
NCT: NCT07641192 · 1225/2025