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

Gingivitis Clinical Trial

Official title:

Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06307041
• Other study ID #: OSATAGUN
• Status: Completed
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: August 11, 2023

Study information

• Verified date: March 2024
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate the effects of 0.2% HA-impregnated dental flosses on the clinical periodontal parameters of patients with gingivitis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 11, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• Dental floss+Gengigel
0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses
• Dental Floss
Dental Flosses

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Üniversitesi Gülhane Dis Hekimligi Fakültesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Özlem SARAÇ ATAGÜN

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Periodontal Parameter-Gingival Index (GI)	Improvement in GI (lower scores mean a better outcome)Minimum score:0 Max.score:3	Baseline-4 weeks
Primary	Clinical Periodontal Parameter-Papillary Bleeding Index (PBI)	Improvement in PBI (lower scores mean a better outcome)Minimum score:0 Max.score:4	Baseline-4 weeks
Primary	Clinical Periodontal Parameter-Plaque Index(PI)	Improvement in PI (lower scores mean a better outcome)Minimum score:0 Max.score:5	Baseline-4 weeks