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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| theranovis dental gel group | Active Comparator | Ten participants will receive the theranovis dental gel |
|
| Placebo group | Placebo Comparator | Ten participants will receive the placebo product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BOP - bleeding on probing | Change in Bleeding on Probing (BOP) percentage | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| PBI - Papillary bleeding index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Behrouz Arefnia,, Univ. ZA Dr.scient.med.dent. | Contact | +4331638530639 | behrouz.arefnia@medunigraz.at | |
| Julia Lüftenegger | Contact | julia.lueftenegger@stud.medunigraz.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Zahnmedizin und Mundgesundheit | Graz | Styria | 8010 | Austria |
The data will be used exclusively for the conduct of the diploma thesis study.
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| 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. |
|
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 |
| D009057 |
| Stomatognathic Diseases |