Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
Primary Purpose
Periodontal Diseases, Periodontal Pocket
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Insulin
Hyaluronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring periodontitis, insulin, regeneration
Eligibility Criteria
Inclusion Criteria: patients diagnosed with periodontitis Exclusion Criteria: patients with systemic illness that contraindicate periodontal surgery
Sites / Locations
- Al-Azhar University, Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1
group 2
Arm Description
Outcomes
Primary Outcome Measures
clinical evaluation
periodontal pocket depth
radiographic evaluation
bone gain assessed by cone beam computed tomography
Secondary Outcome Measures
Full Information
NCT ID
NCT05746676
First Posted
February 13, 2023
Last Updated
February 25, 2023
Sponsor
October University for Modern Sciences and Arts
1. Study Identification
Unique Protocol Identification Number
NCT05746676
Brief Title
Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
Official Title
Clinical and Radiographic Evaluation of Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October University for Modern Sciences and Arts
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
in this study, insulin and hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically
Detailed Description
n this study, insulin versus hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically after a follow up period
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontal Pocket
Keywords
periodontitis, insulin, regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Title
group 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
in treatment of periodontal defects
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Intervention Description
in treatment of periodontal defects
Primary Outcome Measure Information:
Title
clinical evaluation
Description
periodontal pocket depth
Time Frame
6 months
Title
radiographic evaluation
Description
bone gain assessed by cone beam computed tomography
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients diagnosed with periodontitis
Exclusion Criteria:
patients with systemic illness that contraindicate periodontal surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naglaa El-Wakeel, Prof.
Phone
+2 01001757761
Email
naglaelwakeel@gmail.com
Facility Information:
Facility Name
Al-Azhar University, Faculty of Dentistry
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inas Motawe, prof
Phone
01010112121
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
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