Gingivitis, Oral Health Care
Conditions
Keywords
theranovis dental gel, gingivitis
Brief summary
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
OTHERtheranovis 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.
OTHERPlacebo 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.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BOP - bleeding on probing | 8 weeks | Change in Bleeding on Probing (BOP) percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PI - Plaque Index | 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. |
| PBI - Papillary bleeding index | 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. |
Countries
Austria
Contacts
CONTACTBehrouz Arefnia,, Univ. ZA Dr.scient.med.dent.
CONTACTJulia Lüftenegger
Outcome results
None listed