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

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ClinicalTrials.gov Identifier: NCT03807596
Recruitment Status : Completed
First Posted : January 17, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Gihane Gharib Madkour, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Periodontal treatment with Hyaluronic acid associated with SRP Procedure: Scaling & root planning alone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 16, 2017
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : June 29, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   38 Months to 56 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807596


Locations
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Egypt
Faculty of Dentistry, Cairo University
Cairo, Egypt, 12411
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Gihane G Madkour, Ass Prof Cairo University

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Responsible Party: Gihane Gharib Madkour, Associate Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03807596     History of Changes
Other Study ID Numbers: 15062011
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents