Clincosm LogoSign in Get a demo

Application of Hyaluronic Acid in Diabetes

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05543434
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyaluronic acid
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of The Clinical & Radiographic Parameters in Controlled Type 2 Diabetic Patients Treated With Non-Surgical Periodontal Therapy With & Without Using Hyaluronic Acid Gel
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: hyaluronic acid

Application of crosslinked HA gel in pockets after subgingival debridement immediately and one week after.

Drug: Hyaluronic acid
anti-inflammatory, anti-edematous, osseoinductive.
Other Names:
  • Gingigel /Germany

    		•
    Active Comparator: scaling and root planing

    scaling and root planing using ultrasonic scaler and hand instruments.

    Drug: Hyaluronic acid
    anti-inflammatory, anti-edematous, osseoinductive.
    Other Names:
  • Gingigel /Germany

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical attachment level gain [3 months]

      Clinical attachment gain by using UNC15 Periodontal probe/ numerical data

    Secondary Outcome Measures

    1. Pocket depth reduction [3 moths]

      Pocket depth reduction by using UNC15 Periodontal probe/ numerical data

    2. Bleeding on probing [3 months]

      Bleeding on probing by using UNC15 Periodontal probe/ binary data

    3. Gingival Recession [3 months]

      Gingival Recession by using UNC15 Periodontal probe/ numerical data

    4. Radiographic Evaluation [3 months]

      by using periapical radiograph with standardized acrylic stent

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 faculty of dentistry Cairo university Cairo Egypt 12311

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Reem M Alabbadi, BDS, master student
    • Study Director: Nesma M Shemais, PHD, Lecturer of Oral Medicine and Periodontology- faculty of dentistry/Cairo University
    • Study Chair: Karim F Elsayed, professor, Associate Professor of Oral Medicine and Periodontology-Cairo UniversityClinical director of oral medicine and periodontology clinics, Faculty of Dentistry, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reem Mohammed Ahmed Al-abbadi, dentist, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05543434
    Other Study ID Numbers:
    • Reem
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontal Diseases
    Hyaluronic Acid

    Study Results

    No Results Posted as of Sep 16, 2022