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NCT03807596 Clinical Trial

Hyaluronic Acid With Scaling & Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2

Chronic Periodontitis Clinical Trial

Official title:
Adjunctive Use Of Hyaluronic Acid With Scaling & Root Planing In Treatment of Chronic Periodontitis Patients With Diabetes Mellitus Type 2: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03807596
Other study ID # 15062011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2017
Est. completion date June 29, 2017

Study information
Verified date January 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling & root planing (SRP) in patients with chronic periodontitis & diabetes mellitus type 2.

Description:

Thirty subjects with chronic periodontitis & diabetes mellitus type 2 were included in this randomized clinical trial. These subjects were randomly allocated into test & control equal groups. The test group comprised fifteen patients who received SRP with subgingival application of Hyaluronic acid as an adjunct. The control group included fifteen patients who received SRP alone. Plaque index (PI), gingival index (GI), probing depth (PD) & clinical attachment level (CAL) were measured & documented at baseline, 6 weeks & 12 weeks intervals.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 29, 2017
Est. primary completion date June 29, 2017
Accepts healthy volunteers No
Gender All
Age group 38 Months to 56 Months
Eligibility Inclusion Criteria:

- Patients with chronic periodontitis and type 2 diabetes mellitus

- Minimum of 20 teeth

- Clinical attachment level (CAL) = 3 mm

- Probing depth (PD) = 4 mm.

Exclusion Criteria:

- Pregnant females

- Smokers

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Periodontal treatment with Hyaluronic acid associated with SRP
In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.
• Scaling & root planning alone
Patients received full-mouth supra- & sub-gingival SRP with the use of ultrasonic device & periodontal universal & Gracey curettes under local anesthesia.

Locations
Country Name City State
Egypt Faculty of Dentistry, Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gain in clinical attachment level Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe 12 weeks
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