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Completed

NCT Number: NCT06309797

Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis

This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 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

The additional use of agents with antibacterial and anti-inflammatory activities such as hyaluronic acid (HA) in treating periodontal disease has recently become popular. This study aimed to evaluate the effects of using an interdental brush dipped in 0.2% HA gel on clinical periodontal parameters.This randomized controlled trial was conducted among 33 female patients and 27 male patients with stage II/III grade A/B periodontitis. After the initial periodontal treatment, patients were randomly divided into two groups; those in the test group were asked to use an interdental brush dipped in 0.2% HA gel twice a day after brushing, while those in the control group were asked to use a regular interdental brush. Clinical periodontal parameters including the pocket depth, clinical attachment loss, gingival index, plaque index, and papillary bleeding index (PBI) were assessed at baseline and in the 1st and 3rd months 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 periodontitis (Stage 3)
  • 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

Interdental brush+HA

Device

interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm) +20 mL of 0.2% HA gel (Gengigel; Ricerfarma, Milan, Italy)

Interdental Brush

Device

interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm)

Primary outcomes

  1. Gingival index (GI)

    Time frame: Baseline-4 weeks-12 weeks

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

  2. Plaque index (PI)

    Time frame: Baseline-4 weeks-12 weeks

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

  3. Papillary bleeding index (PBI)

    Time frame: Baseline-4 weeks-12 weeks

    Improvement in PBI; lower scores mean a better outcome; Minimum score:0 Max.score: 3

  4. Pocket depth (PD)

    Time frame: Baseline-4 weeks-12 weeks

    Improvement in PD; lower scores mean a better outcome

  5. Clinical attachment loss (CAL)

    Time frame: Baseline-4 weeks-12 weeks

    Improvement in CAL; lower scores mean a better outcome

Sponsors and collaborators

Lead sponsor

Özlem SARAÇ ATAGÜN

Other

Registry information

Official study title

Evaluation of the Effects of Using an Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Clinical Periodontal Parameters Among Patients With Periodontitis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2024
Registry last updated
Mar 13, 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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