Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis

NCT ID: NCT06309797

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-02

Study Completion Date

2024-02-05

Brief Summary

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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

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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

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single-center, single-blinded, randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The investigator carrying out the measurements was not aware of which patients were assigned to the test group.

Study Groups

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Test (HA group)

the test group were asked to brush their teeth, dip the interdental brush in HA gel, and use the dipped interdental brush.

Group Type EXPERIMENTAL

Interdental brush+HA

Intervention Type DEVICE

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)

Control Group

the control group were asked to brush their teeth and use the interdental brush for oral hygiene.

Group Type EXPERIMENTAL

Interdental brush

Intervention Type DEVICE

interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm)

Interventions

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Interdental brush+HA

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)

Intervention Type DEVICE

Interdental brush

interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. ≥18-55 years of age
2. Being systemically healthy
3. Having periodontitis (Stage 3)
4. Not to have used any medication in the last three months
5. Not smoking
6. Right-handed
7. At least 20 natural teeth

Exclusion Criteria

1. Patients with interdental caries
2. Patients with orthodontic appliances
3. Patients with removable (partial) prostheses
4. Patients with oral and/or peri-oral pain
5. Patients with significant oral lesions
6. Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding
7. Patients who have undergone periodontal treatment within the last 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Özlem SARAÇ ATAGÜN

OTHER

Sponsor Role lead

Responsible Party

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Özlem SARAÇ ATAGÜN

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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özlem saraç atagün, PhD

Role: PRINCIPAL_INVESTIGATOR

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD

Locations

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Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 40281514 (View on PubMed)

Other Identifiers

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OSATAGUN2

Identifier Type: -

Identifier Source: org_study_id

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