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

NCT06309797 | Completed

• 1 other identifier: OSATAGUN2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis

Keywords

Periodontitis; Hyaluronic Acid; Oral Hygiene

Outcome Measures

Primary Outcomes (5)

• Gingival index (GI)

  Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3

  Baseline-4 weeks-12 weeks

• Plaque index (PI)

  Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5

  Baseline-4 weeks-12 weeks

• Papillary bleeding index (PBI)

  Improvement in PBI; lower scores mean a better outcome; Minimum score:0 Max.score: 3

  Baseline-4 weeks-12 weeks

• Pocket depth (PD)

  Improvement in PD; lower scores mean a better outcome

  Baseline-4 weeks-12 weeks

• Clinical attachment loss (CAL)

  Improvement in CAL; lower scores mean a better outcome

  Baseline-4 weeks-12 weeks

Study Arms (2)

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.

Device: Interdental brush+HA

Control Group

EXPERIMENTAL

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

Device: Interdental brush

Interventions

Interdental brush+HA 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)

Test (HA group)

Interdental brush DEVICE

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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Özlem SARAÇ ATAGÜN: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40281514 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• özlem saraç atagün, PhD

  Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator carrying out the measurements was not aware of which patients were assigned to the test group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Model Details: single-center, single-blinded, randomized controlled trial

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 13, 2024
• Study Start: May 2, 2023
• Primary Completion: January 26, 2024
• Study Completion: February 5, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)