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

January 16, 2019 updated by: Gihane Gharib Madkour, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Egypt
      • Cairo, Egypt, 12411
        • 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

3 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SRP group
Chronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling & root planing (SRP) alone.
Procedure: 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.
Experimental: Hyaluronic acid & SRP group
Chronic periodontitis & type 2 diabetes mellitus patients received Periodontal treatment in the form of scaling & root planing (SRP) with the adjunctive use of hyaluronic acid.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gain in clinical attachment level
Time Frame: 12 weeks
Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe
12 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Gihane G Madkour, Ass Prof, 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 (Actual)

March 16, 2017

Primary Completion (Actual)

June 29, 2017

Study Completion (Actual)

June 29, 2017

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15062011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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