Application of Hyaluronic Acid in Diabetes

Not Applicable

Recruiting

• Conditions: Periodontal Diseases
• Interventions: Drug: Hyaluronic acid

• Registration Number: NCT05543434
• Lead Sponsor: Cairo University

Brief Summary

sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.

Detailed Description

To clinically and radiographically evaluate the adjunctive effect of the local application of a 0.8% hyaluronan gel in addition to scaling and root planing in treatment of controlled diabetic patients with stage II periodontitis.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-16
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-21
• Study Start: 2022-12-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Age ≥ 18 years.
• Patient with controlled diabetic type 2 (HgA1C <7) (Mori et al., 2021).
• Periodontitis stage II.
• Periodontitis grade B.
• Pocket depth > 4 mm.
• Smoking ≤ 10 cigarettes/day.
• Cooperative patients able and accept to come for follow up appointments

Exclusion Criteria

• • The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.

  • Having surgical therapy or undergoing orthodontic treatment.
  • Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
  • Pregnant and lactation females.
  • Smoking ˃ 10 cigarettes/day.
  • Patients with poor oral hygiene.
  • Any known allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
scaling and root planing	Hyaluronic acid	scaling and root planing using ultrasonic scaler and hand instruments.
hyaluronic acid	Hyaluronic acid	Application of crosslinked HA gel in pockets after subgingival debridement immediately and one week after.

Primary Outcome Measures

Name	Time	Method
Clinical attachment level gain	3 months	Clinical attachment gain by using UNC15 Periodontal probe/ numerical data

Secondary Outcome Measures

Name	Time	Method
Pocket depth reduction	3 moths	Pocket depth reduction by using UNC15 Periodontal probe/ numerical data
Bleeding on probing	3 months	Bleeding on probing by using UNC15 Periodontal probe/ binary data
Gingival Recession	3 months	Gingival Recession by using UNC15 Periodontal probe/ numerical data
Radiographic Evaluation	3 months	by using periapical radiograph with standardized acrylic stent

Trial Locations

Locations (1)

faculty of dentistry Cairo university; 🇪🇬 Cairo, Egypt