Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses on Clinical Gingival Parameters
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2023
CompletedFirst Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedMarch 12, 2024
March 1, 2024
3 months
February 28, 2024
March 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Clinical Periodontal Parameter-Gingival Index (GI)
Improvement in GI (lower scores mean a better outcome)Minimum score:0 Max.score:3
Baseline-4 weeks
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
Clinical Periodontal Parameter-Plaque Index(PI)
Improvement in PI (lower scores mean a better outcome)Minimum score:0 Max.score:5
Baseline-4 weeks
Study Arms (2)
Test (HA group)
OTHEROne side is HA gel impregnated dental floss usage
Control Group
OTHEROne side is dental floss usage
Interventions
Eligibility Criteria
You may qualify if:
- ≥18-55 years of age
- Being systemically healthy
- Having gingivitis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
Ankara, 06010, Turkey (Türkiye)
Related Publications (1)
Atagun OS, Sen SC, Ustaoglu G, Ozcan E. Effects of 0.2% Hyaluronic Acid Gel-Impregnated Dental Floss on Clinical Gingival Parameters: A Randomised Clinical Trial. Int J Dent Hyg. 2025 May;23(2):312-318. doi: 10.1111/idh.12856. Epub 2024 Oct 29.
PMID: 39473003DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
özlem saraç atagün, PhD
Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The investigator who performed the measurements was blinded to which side of patients was the test group
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 12, 2024
Study Start
April 3, 2023
Primary Completion
July 7, 2023
Study Completion
August 11, 2023
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share