PeriodontitisNCT06309797
Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis
A study testing Interdental brush+HA and Interdental brush in people with Periodontitis, run by Özlem SARAÇ ATAGÜN at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Interdental brush+HA and Interdental brush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 5 Feb 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18-55 years of age
- Being systemically healthy
- Having periodontitis (Stage 3)
- 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: Evaluation of the Effects of Using an Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Clinical Periodontal Parameters Among Patients With Periodontitis
This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis.
Read the detailed description
The additional use of agents with antibacterial and anti-inflammatory activities such as hyaluronic acid (HA) in treating periodontal disease has recently become popular. This study aimed to evaluate the effects of using an interdental brush dipped in 0.2% HA gel on clinical periodontal parameters.This randomized controlled trial was conducted among 33 female patients and 27 male patients with stage II/III grade A/B periodontitis. After the initial periodontal treatment, patients were randomly divided into two groups; those in the test group were asked to use an interdental brush dipped in 0.2% HA gel twice a day after brushing, while those in the control group were asked to use a regular interdental brush. Clinical periodontal parameters including the pocket depth, clinical attachment loss, gingival index, plaque index, and papillary bleeding index (PBI) were assessed at baseline and in the 1st and 3rd months after treatment.
- Conditions
- Periodontitis
- Being tested
- Interdental brush+HA, Interdental brush
- Keywords
- Periodontitis, Hyaluronic Acid, Oral Hygiene
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdental brush+HADevice
interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm) +20 mL of 0.2% HA gel (Gengigel; Ricerfarma, Milan, Italy)
Interdental brushDevice
interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm)
| Study group | Role | What they receive |
|---|---|---|
| Test (HA group) | Experimental | the test group were asked to brush their teeth, dip the interdental brush in HA gel, and use the dipped interdental brush. Receives: Device: Interdental brush+HA |
| Control Group | Experimental | the control group were asked to brush their teeth and use the interdental brush for oral hygiene. Receives: Device: Interdental brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index (GI)
Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Measured: Baseline-4 weeks-12 weeks
Plaque index (PI)
Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5
Measured: Baseline-4 weeks-12 weeks
Papillary bleeding index (PBI)
Improvement in PBI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Measured: Baseline-4 weeks-12 weeks
Pocket depth (PD)
Improvement in PD; lower scores mean a better outcome
Measured: Baseline-4 weeks-12 weeks
Clinical attachment loss (CAL)
Improvement in CAL; lower scores mean a better outcome
Measured: Baseline-4 weeks-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start2 May 2023
- Primary completion26 Jan 2024
- Study completion5 Feb 2024
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 PeriodontitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, single-blinded, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 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
- NCT06309797
- Sponsor's protocol ID
- OSATAGUN2
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarac Atagun O, Ceylan Sen S, Ustaoglu G, Ozcan E. Evaluation of the effects of using an interdental brush dipped in 0.2% hyaluronic acid gel on clinical periodontal parameters among patients with periodontitis: a randomized controlled trial. BMC Oral Health. 2025 Apr 25;25(1):635. doi: 10.1186/s12903-025-06038-7.
PubMed 40281514
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Using an Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Clinical Periodontal Parameters Among Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT06309797
- Acronym / sponsor ID
- OSATAGUN2
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Hyaluronic Acid, Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Özlem SARAÇ ATAGÜNUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 13 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 compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis.
Detailed description
The additional use of agents with antibacterial and anti-inflammatory activities such as hyaluronic acid (HA) in treating periodontal disease has recently become popular. This study aimed to evaluate the effects of using an interdental brush dipped in 0.2% HA gel on clinical periodontal parameters.This randomized controlled trial was conducted among 33 female patients and 27 male patients with stage II/III grade A/B periodontitis. After the initial periodontal treatment, patients were randomly divided into two groups; those in the test group were asked to use an interdental brush dipped in 0.2% HA gel twice a day after brushing, while those in the control group were asked to use a regular interdental brush. Clinical periodontal parameters including the pocket depth, clinical attachment loss, gingival index, plaque index, and papillary bleeding index (PBI) were assessed at baseline and in the 1st and 3rd months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- single-center, single-blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Test (HA group) | Experimental | Device: Interdental brush+HAthe test group were asked to brush their teeth, dip the interdental brush in HA gel, and use the dipped interdental brush. |
| Control Group | Experimental | Device: Interdental brushthe control group were asked to brush their teeth and use the interdental brush for oral hygiene. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18-55 years of age
- Being systemically healthy
- Having periodontitis (Stage 3)
- 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 |
|---|---|---|
| Interdental brush+HAinterdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm) +20 mL of 0.2% HA gel (Gengigel; Ricerfarma, Milan, Italy) | Device | Test (HA group) |
| Interdental brushinterdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm) | Device | Control Group |
Primary outcome
Gingival index (GI)
Time frame: Baseline-4 weeks-12 weeks
Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Plaque index (PI)
Time frame: Baseline-4 weeks-12 weeks
Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5
Papillary bleeding index (PBI)
Time frame: Baseline-4 weeks-12 weeks
Improvement in PBI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Pocket depth (PD)
Time frame: Baseline-4 weeks-12 weeks
Improvement in PD; lower scores mean a better outcome
Clinical attachment loss (CAL)
Time frame: Baseline-4 weeks-12 weeks
Improvement in CAL; lower scores mean a better outcome
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 13 Mar 2024.
- Derived from this study: PubMed 40281514Sarac Atagun O, Ceylan Sen S, Ustaoglu G, Ozcan E. Evaluation of the effects of using an interdental brush dipped in 0.2% hyaluronic acid gel on clinical periodontal parameters among patients with periodontitis: a randomized controlled trial. BMC Oral Health. 2025 Apr 25;25(1):635. doi: 10.1186/s12903-025-06038-7.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 Interdental brush+HA and Interdental brush in people with Periodontitis, 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 13 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?
Gingival index (GI) (time frame: Baseline-4 weeks-12 weeks). The study lists 5 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 NCT06309797, 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 13 Mar 2024.