GingivitisNCT07641192
Theranovis Dental Gel in Patients With Gingivitis
A study testing theranovis dental gel group in people with Gingivitis and Oral Health Care, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis, Oral Health Care
- What is being tested?
- theranovis dental gel group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Julia Lüftenegger contact
Austria1 site
Universitätsklinik für Zahnmedizin und Mundgesundheit
Graz, Styria, 8010
About this study
Official title: The Effects of Theranovis Dental Gel in Patients With Gingivitis: A Prospective Pilot Study
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.
Read the 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.
- Conditions
- Gingivitis, Oral Health Care
- Being tested
- theranovis dental gel group, Placebo group
- Keywords
- theranovis dental gel, gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theranovis dental gel groupOther
Also called Placebo 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.
Placebo 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.
| Study group | Role | What they receive |
|---|---|---|
| theranovis dental gel group | Active comparator | Ten participants will receive the theranovis dental gel Receives: Other: theranovis dental gel group |
| Placebo group | Placebo comparator | Ten participants will receive the placebo product Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOP - bleeding on probing
Change in Bleeding on Probing (BOP) percentage
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641192
- Sponsor's protocol ID
- 1225/2025
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be used exclusively for the conduct of the diploma thesis study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Theranovis Dental Gel in Patients With Gingivitis: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07641192
- Acronym / sponsor ID
- 1225/2025
- Conditions
- Gingivitis, Oral Health Care
- Keywords
- theranovis dental gel, gingivitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| theranovis dental gel group | Active comparator | Other: theranovis dental gel groupTen participants will receive the theranovis dental gel |
| Placebo group | Placebo comparator | Other: Placebo groupTen participants will receive the placebo product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| theranovis dental gel groupAlso: Placebo groupThe 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 | theranovis dental gel group |
| Placebo groupThe 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 | Placebo group |
Primary outcome
BOP - bleeding on probing
Time frame: 8 weeks
Change in Bleeding on Probing (BOP) percentage
2 secondary outcomes
PI - Plaque Index
Time frame: 8 weeks
PBI - Papillary bleeding index
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. The data will be used exclusively for the conduct of the diploma thesis study.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Lüftenegger contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing theranovis dental gel group in people with Gingivitis and Oral Health Care, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Behrouz Arefnia,, Univ. ZA Dr.scient.med.dent. (+4331638530639, behrouz.arefnia@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOP - bleeding on probing (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.