Health TrialsbyHealthPanel

Theranovis Dental Gel in Patients With Gingivitis

ConditionsGingivitisOral Health Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Graz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • theranovis dental gel group

    Other intervention

    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.

  • Placebo group

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: theranovis dental gel groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

BOP - bleeding on probing

Change in Bleeding on Probing (BOP) percentage

Time frame
8 weeks

Secondary outcomes

1

PI - Plaque Index

Plaque Index (Silness and Löe) Scale from 0 to 3. Higher scores indicate greater plaque accumulation and therefore a worse oral health status.

Time frame
8 weeks
2

PBI - Papillary bleeding index

Papillary bleeding index (Saxer and Mühlemann) Scale from 0 to 4. Higher scores indicate more severe gingival inflammation and therefore a worse outcome.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Graz

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: