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NCT Number: NCT06307041

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

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

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Key information

Age range

18 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

Dental floss+Gengigel

Device

0.2% Hyaluronic Acid Gel-Impregnated Dental Flosses

Dental Floss

Device

Dental Flosses

Primary outcomes

  1. Clinical Periodontal Parameter-Gingival Index (GI)

    Time frame: Baseline-4 weeks

    Improvement in GI (lower scores mean a better outcome)Minimum score:0 Max.score:3

  2. Clinical Periodontal Parameter-Papillary Bleeding Index (PBI)

    Time frame: Baseline-4 weeks

    Improvement in PBI (lower scores mean a better outcome)Minimum score:0 Max.score:4

  3. Clinical Periodontal Parameter-Plaque Index(PI)

    Time frame: Baseline-4 weeks

    Improvement in PI (lower scores mean a better outcome)Minimum score:0 Max.score:5

Sponsors and collaborators

Lead sponsor

Özlem SARAÇ ATAGÜN

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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