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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06307041
Enrollment
30
Registered
2024-03-12
Start date
2023-04-03
Completion date
2023-08-11
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

Keywords

Hyaluronic Acid, Dental Floss, Gingivitis, Oral Hygiene

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.

Interventions

DEVICEDental floss+Gengigel

0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses

Dental Flosses

Sponsors

Özlem SARAÇ ATAGÜN
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Masking description

The investigator who performed the measurements was blinded to which side of patients was the test group

Intervention model description

single-center, single-blinded, split-mouth, randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 47 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Periodontal Parameter-Gingival Index (GI)Baseline-4 weeksImprovement in GI (lower scores mean a better outcome)Minimum score:0 Max.score:3
Clinical Periodontal Parameter-Papillary Bleeding Index (PBI)Baseline-4 weeksImprovement in PBI (lower scores mean a better outcome)Minimum score:0 Max.score:4
Clinical Periodontal Parameter-Plaque Index(PI)Baseline-4 weeksImprovement in PI (lower scores mean a better outcome)Minimum score:0 Max.score:5

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026