Back to resultsHyaluronic Acid With Scaling & Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Periodontal treatment with Hyaluronic acid associated with SRP
Scaling & root planning alone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility 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
Sites / Locations
- Faculty of Dentistry, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
SRP group
Hyaluronic acid & SRP group
Arm Description
Chronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling & root planing (SRP) alone.
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.
Outcomes
Primary Outcome Measures
Gain in clinical attachment level
Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03807596
Brief Title
Hyaluronic Acid With Scaling & Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SRP group
Arm Type
Active Comparator
Arm Description
Chronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling & root planing (SRP) alone.
Arm Title
Hyaluronic acid & SRP group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Periodontal treatment with Hyaluronic acid associated with SRP
Intervention Description
In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.
Intervention Type
Procedure
Intervention Name(s)
Scaling & root planning alone
Intervention Description
Patients received full-mouth supra- & sub-gingival SRP with the use of ultrasonic device & periodontal universal & Gracey curettes under local anesthesia.
Primary Outcome Measure Information:
Title
Gain in clinical attachment level
Description
Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
38 Months
Maximum Age & Unit of Time
56 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihane G Madkour, Ass Prof
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
12411
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyaluronic Acid With Scaling & Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2
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