Theranovis Dental Gel in Patients With Gingivitis

June 8, 2026 updated by: Medical University of Graz

The Effects of Theranovis Dental Gel in Patients With Gingivitis: A Prospective Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • Universitätsklinik für Zahnmedizin und Mundgesundheit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: theranovis dental gel group
Ten participants will receive the theranovis dental gel
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 Names:
  • Placebo group
Placebo Comparator: Placebo group
Ten participants will receive the placebo product
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOP - bleeding on probing
Time Frame: 8 weeks
Change in Bleeding on Probing (BOP) percentage
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PI - Plaque Index
Time Frame: 8 weeks

Plaque Index (Silness and Löe) Scale from 0 to 3.

Higher scores indicate greater plaque accumulation and therefore a worse oral health status.
8 weeks
PBI - Papillary bleeding index
Time Frame: 8 weeks
Papillary bleeding index (Saxer and Mühlemann) Scale from 0 to 4. Higher scores indicate more severe gingival inflammation and therefore a worse outcome.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1225/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be used exclusively for the conduct of the diploma thesis study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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