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Application of Hyaluronic Acid in Diabetes

Primary Purpose

Periodontal Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Hyaluronic acid

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

faculty of dentistry Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hyaluronic acid

scaling and root planing

Arm Description

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

scaling and root planing using ultrasonic scaler and hand instruments.

Outcomes

Primary Outcome Measures

Clinical attachment level gain

Clinical attachment gain by using UNC15 Periodontal probe/ numerical data

Secondary Outcome Measures

Pocket depth reduction

Pocket depth reduction by using UNC15 Periodontal probe/ numerical data

Bleeding on probing

Bleeding on probing by using UNC15 Periodontal probe/ binary data

Gingival Recession

Gingival Recession by using UNC15 Periodontal probe/ numerical data

Radiographic Evaluation

by using periapical radiograph with standardized acrylic stent

Full Information

NCT ID

NCT05543434

First Posted

September 14, 2022

Last Updated

September 16, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05543434

Brief Title

Application of Hyaluronic Acid in Diabetes

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Anticipated)

Primary Completion Date

March 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hyaluronic acid

Arm Type

Experimental

Arm Description

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

Arm Title

scaling and root planing

Arm Type

Active Comparator

Arm Description

scaling and root planing using ultrasonic scaler and hand instruments.

Intervention Type

Drug

Intervention Name(s)

Hyaluronic acid

Other Intervention Name(s)

Gingigel /Germany

Intervention Description

anti-inflammatory, anti-edematous, osseoinductive.

Primary Outcome Measure Information:

Title

Clinical attachment level gain

Description

Clinical attachment gain by using UNC15 Periodontal probe/ numerical data

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Pocket depth reduction

Description

Pocket depth reduction by using UNC15 Periodontal probe/ numerical data

Time Frame

3 moths

Title

Bleeding on probing

Description

Bleeding on probing by using UNC15 Periodontal probe/ binary data

Time Frame

3 months

Title

Gingival Recession

Description

Gingival Recession by using UNC15 Periodontal probe/ numerical data

Time Frame

3 months

Title

Radiographic Evaluation

Description

by using periapical radiograph with standardized acrylic stent

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Reem M Alabbadi, BDS

Phone

00201551563633

reem.alabbadi@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Nesma M Shemais, PHD

Phone

00201005615697

nesma.shemais@dentistry.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reem M Alabbadi, BDS

Organizational Affiliation

master student

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nesma M Shemais, PHD

Organizational Affiliation

Lecturer of Oral Medicine and Periodontology- faculty of dentistry/Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Karim F Elsayed, professor

Organizational Affiliation

Associate Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University

Official's Role

Study Chair

Facility Information:

Facility Name

faculty of dentistry Cairo university

City

Cairo

ZIP/Postal Code

12311

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nesma M Shemais, PHD

Phone

00201005615697

nesma.shemais@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Application of Hyaluronic Acid in Diabetes

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