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NCT Number: NCT07641192

Theranovis Dental Gel in Patients With Gingivitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinik für Zahnmedizin und Mundgesundheit

Graz, Styria, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

theranovis dental gel group

Other

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 Group

Other

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 outcomes

  1. BOP - bleeding on probing

    Time frame: 8 weeks

    Change in Bleeding on Probing (BOP) percentage

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Behrouz Arefnia,, Univ. ZA Dr.scient.med.dent.

CONTACT

[email protected]

+4331638530639

Julia Lüftenegger

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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