ClinicalTrials.gg
Not yet recruitingNCT07641192Updated Jun 11, 2026

Theranovis Dental Gel in Patients With Gingivitis

An interventional study of theranovis dental gel group and Placebo group in Gingivitis and Oral Health Care, sponsored by Medical University of Graz. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gingivitis
  • Oral Health Care

Browse trials for

Keywords

  • theranovis dental gel
  • gingivitis
03

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's planned enrollment of 20 is below the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Male and female participants under 18 years of age
  • Fewer than 12 teeth per jaw
  • Individuals not capable of giving
  • Individuals with 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    theranovis dental gel group

    Ten participants will receive the theranovis dental gel

    Other: theranovis dental gel group

  • Placebo comparator
    Placebo group

    Ten participants will receive the placebo product

    Other: Placebo group

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.

    Also known as: Placebo group

  • 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.

06

What researchers measure

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

07

Study locations

1 site
  • Universitätsklinik für Zahnmedizin und Mundgesundheit
    Graz, Styria 8010, Austria
08

References and documents

Individual participant data

Plan to share: No — The data will be used exclusively for the conduct of the diploma thesis study.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Apr 2027, 10 months later.

Of 204 non-industry interventional studies with no phase under Gingivitis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's planned 10 months is above that.

Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2026
First posted
Jun 11, 2026
StartEst.
Jun 2026
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Jun 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07641192
Responsible party
Sponsor
First posted
Jun 11, 2026
Start date
Jun 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jun 11, 2026

Study contacts

Behrouz Arefnia,, Univ. ZA Dr.scient.med.dent.
Contact
behrouz.arefnia@medunigraz.at
+4331638530639
Julia Lüftenegger
Contact
julia.lueftenegger@stud.medunigraz.at

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion