Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Device: Dental floss+Gengigel; Device: Dental Floss

• Registration Number: NCT06307041
• Lead Sponsor: Özlem SARAÇ ATAGÜN

Brief Summary

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 Timeline

• Study Start: 2023-04-03
• Primary Completion: 2023-07-07
• Study Completion: 2023-08-11
• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-06
• Last Update Submitted: 2024-03-06
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. ≥18-55 years of age
2. Being systemically healthy
3. Having gingivitis
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: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Test (HA group)	Dental floss+Gengigel	One side is HA gel impregnated dental floss usage
Control Group	Dental Floss	One side is dental floss usage

Primary Outcome Measures

Name	Time	Method
Clinical Periodontal Parameter-Gingival Index (GI)	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)	Baseline-4 weeks	Improvement in PBI (lower scores mean a better outcome)Minimum score:0 Max.score:4
Clinical Periodontal Parameter-Plaque Index(PI)	Baseline-4 weeks	Improvement in PI (lower scores mean a better outcome)Minimum score:0 Max.score:5

Trial Locations

Locations (1)

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