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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
October University for Modern Sciences and Arts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring periodontitis, insulin, regeneration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
February 13, 2023
Last Updated
February 25, 2023
Sponsor
October University for Modern Sciences and Arts
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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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