GingivitisNCT06307041
Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters
A study testing Dental floss+Gengigel and Dental Floss in people with Gingivitis, run by Özlem SARAÇ ATAGÜN at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of 0.2% HA-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 47 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Dental floss+Gengigel and Dental Floss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2023to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥18-55 years of age
- Being systemically healthy
- Having gingivitis
- Not to have used any medication in the last three months
- Not smoking
- Right-handed
- At least 20 natural teeth
Who cannot join
- Patients with interdental caries
- Patients with orthodontic appliances
- Patients with removable (partial) prostheses
- Patients with oral and/or peri-oral pain
- Patients with significant oral lesions
- Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding
- Patients who have undergone periodontal treatment within the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
Ankara, 06010
About this study
Official title: Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters: A Randomized Clinical Trial
This study aimed to evaluate the effects of 0.2% HA-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis.
Read the detailed description
Gingivitis is a common inflammatory lesion caused by the build-up of oral biofilm and is an essential precursor to periodontitis. For its treatment, oral hygiene habits, such as dental flossing, must be improved, and adjunctive materials, such as hyaluronic acid, may be used to reduce plaque formation and gingival inflammation. This study aimed to assess the effects of 0.2% hyaluronic acid gel (Gengigel®)-impregnated dental flosses on the clinical periodontal markers of patients with gingivitis.
This clinical study adopted a split-mouth, randomized controlled trial design. After clinical data were assessed at baseline, and supragingival scaling and planing was performed, bilateral gingivitis regions were randomly allocated to either a test group (hyaluronic acid gel-impregnated floss) or a control group (regular floss) using a computer-generated randomization table. Clinical parameters were recorded at 1, 2, and 4 weeks after treatment.
- Conditions
- Gingivitis
- Being tested
- Dental floss+Gengigel, Dental Floss
- Keywords
- Hyaluronic Acid, Dental Floss, Gingivitis, Oral Hygiene
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental floss+GengigelDevice
0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses
Dental FlossDevice
Dental Flosses
| Study group | Role | What they receive |
|---|---|---|
| Test (HA group) | Other | One side is HA gel impregnated dental floss usage Receives: Device: Dental floss+Gengigel |
| Control Group | Other | One side is dental floss usage Receives: Device: Dental Floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Periodontal Parameter-Gingival Index (GI)
Improvement in GI (lower scores mean a better outcome)Minimum score:0 Max.score:3
Measured: Baseline-4 weeks
Clinical Periodontal Parameter-Papillary Bleeding Index (PBI)
Improvement in PBI (lower scores mean a better outcome)Minimum score:0 Max.score:4
Measured: Baseline-4 weeks
Clinical Periodontal Parameter-Plaque Index(PI)
Improvement in PI (lower scores mean a better outcome)Minimum score:0 Max.score:5
Measured: Baseline-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start3 Apr 2023
- Primary completion7 Jul 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- single-center, single-blinded, split-mouth, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Özlem SARAÇ ATAGÜN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Özlem SARAÇ ATAGÜN, Saglik Bilimleri Universitesi
- Investigators
- özlem saraç atagün, PhD, Principal investigator, Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307041
- Sponsor's protocol ID
- OSATAGUN
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atagun OS, Sen SC, Ustaoglu G, Ozcan E. Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Floss on Clinical Gingival Parameters: A Randomised Clinical Trial. Int J Dent Hyg. 2025 May;23(2):312-318. doi: 10.1111/idh.12856. Epub 2024 Oct 29.
PubMed 39473003
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06307041
- Acronym / sponsor ID
- OSATAGUN
- Conditions
- Gingivitis
- Keywords
- Hyaluronic Acid, Dental Floss, Gingivitis, Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Özlem SARAÇ ATAGÜNUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 12 Mar 2024 (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.
This study aimed to evaluate the effects of 0.2% HA-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis.
Detailed description
Gingivitis is a common inflammatory lesion caused by the build-up of oral biofilm and is an essential precursor to periodontitis. For its treatment, oral hygiene habits, such as dental flossing, must be improved, and adjunctive materials, such as hyaluronic acid, may be used to reduce plaque formation and gingival inflammation. This study aimed to assess the effects of 0.2% hyaluronic acid gel (Gengigel®)-impregnated dental flosses on the clinical periodontal markers of patients with gingivitis.
This clinical study adopted a split-mouth, randomized controlled trial design. After clinical data were assessed at baseline, and supragingival scaling and planing was performed, bilateral gingivitis regions were randomly allocated to either a test group (hyaluronic acid gel-impregnated floss) or a control group (regular floss) using a computer-generated randomization table. Clinical parameters were recorded at 1, 2, and 4 weeks after treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- single-center, single-blinded, split-mouth, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test (HA group) | Other | Device: Dental floss+GengigelOne side is HA gel impregnated dental floss usage |
| Control Group | Other | Device: Dental FlossOne side is dental floss usage |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- ≥18-55 years of age
- Being systemically healthy
- Having gingivitis
- Not to have used any medication in the last three months
- Not smoking
Key exclusion criteria (7 listed)
- Patients with interdental caries
- Patients with orthodontic appliances
- Patients with removable (partial) prostheses
- Patients with oral and/or peri-oral pain
- Patients with significant oral lesions
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 |
|---|---|---|
| Dental floss+Gengigel0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses | Device | Test (HA group) |
| Dental FlossDental Flosses | Device | Control Group |
Primary outcome
Clinical Periodontal Parameter-Gingival Index (GI)
Time frame: Baseline-4 weeks
Improvement in GI (lower scores mean a better outcome)Minimum score:0 Max.score:3
Clinical Periodontal Parameter-Papillary Bleeding Index (PBI)
Time frame: Baseline-4 weeks
Improvement in PBI (lower scores mean a better outcome)Minimum score:0 Max.score:4
Clinical Periodontal Parameter-Plaque Index(PI)
Time frame: Baseline-4 weeks
Improvement in PI (lower scores mean a better outcome)Minimum score:0 Max.score:5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 39473003Atagun OS, Sen SC, Ustaoglu G, Ozcan E. Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Floss on Clinical Gingival Parameters: A Randomised Clinical Trial. Int J Dent Hyg. 2025 May;23(2):312-318. doi: 10.1111/idh.12856. Epub 2024 Oct 29.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
özlem saraç atagün, PhD principal investigator
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental floss+Gengigel and Dental Floss in people with Gingivitis, run by Özlem SARAÇ ATAGÜN at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 12 Mar 2024. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Periodontal Parameter-Gingival Index (GI) (time frame: Baseline-4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307041, which also lists 1 linked publication.
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 12 Mar 2024.