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

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Device: Interdental brush+HA; Device: Interdental brush

• Registration Number: NCT06309797
• Lead Sponsor: Özlem SARAÇ ATAGÜN

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.

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 Timeline

• Study Start: 2023-05-02
• Primary Completion: 2024-01-26
• Study Completion: 2024-02-05
• Study First Submitted: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test (HA group)	Interdental brush+HA	the test group were asked to brush their teeth, dip the interdental brush in HA gel, and use the dipped interdental brush.
Control Group	Interdental brush	the control group were asked to brush their teeth and use the interdental brush for oral hygiene.

Primary Outcome Measures

Name	Time	Method
Plaque index (PI)	Baseline-4 weeks-12 weeks	Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5
Gingival index (GI)	Baseline-4 weeks-12 weeks	Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Pocket depth (PD)	Baseline-4 weeks-12 weeks	Improvement in PD; lower scores mean a better outcome
Papillary bleeding index (PBI)	Baseline-4 weeks-12 weeks	Improvement in PBI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Clinical attachment loss (CAL)	Baseline-4 weeks-12 weeks	Improvement in CAL; lower scores mean a better outcome

Trial Locations

Locations (1)

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi; 🇹🇷 Ankara, Turkey