Application of Hyaluronic Acid in Diabetes

September 16, 2022 updated by: Reem Mohammed Ahmed Al-abbadi, Cairo University

Evaluation of The Clinical & Radiographic Parameters in Controlled Type 2 Diabetic Patients Treated With Non-Surgical Periodontal Therapy With & Without Using Hyaluronic Acid Gel

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 12311
        • Recruiting
        • Faculty of Dentistry Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level gain
Time Frame: 3 months
Clinical attachment gain by using UNC15 Periodontal probe/ numerical data
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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, Faculty of Dentistry, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2022

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (ACTUAL)

September 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reem

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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