Theranovis Dental Gel in Patients With Gingivitis

N/ANot Yet RecruitingNCT07641192

Medical University of Graz20 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gingivitis Oral Health Care

Interventions

theranovis dental gel groupOTHER

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 groupOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitätsklinik für Zahnmedizin und Mundgesundheit

Graz, Styria, Austria

Outcomes

Primary Outcomes

BOP - bleeding on probing

Change in Bleeding on Probing (BOP) percentage

Time frame: 8 weeks

Secondary Outcomes

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

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

Central Contacts

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

CONTACT

+4331638530639 behrouz.arefnia@medunigraz.at

Julia Lüftenegger

CONTACT

julia.lueftenegger@stud.medunigraz.at

Data from ClinicalTrials.gov

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