Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects
Primary Purpose
Periodontal Bone Loss, Periodontal Pocket
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
locally injected vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Bone Loss
Eligibility Criteria
Inclusion Criteria:
- patients with infrabony vertical defects
- systemically free patients
- periodontally affected patients
Exclusion Criteria:
- patients with systemic diseases
- smokers
- pregnency
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
non-surgical periodontal regeneration
surgical peridoontal regeneration
Arm Description
non-surgical periodontal regeneration using locally injected vitamin d to treat the infrabony defect
surgical periodontal regeneration using bone graft and collagen barrier
Outcomes
Primary Outcome Measures
radiographic interproximal bone level
radiographic interproximal bone level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03716765
Brief Title
Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects
Official Title
Locally Injected Vitamin D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects: Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
June 2018 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
vitamin D has great role in bone regenration and soft tissue health. in the past periodontal regeneration was performed using bone graft and barrier membrane
Detailed Description
there was no previous studies used the locally injected vitamin d in periodontal regeneration. therefore, we intended to study the effect of locally injected vitamin D in peridoontal regerneration in comparison with the conventional surgical technique
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss, Periodontal Pocket
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-surgical periodontal regeneration
Arm Type
Experimental
Arm Description
non-surgical periodontal regeneration using locally injected vitamin d to treat the infrabony defect
Arm Title
surgical peridoontal regeneration
Arm Type
Active Comparator
Arm Description
surgical periodontal regeneration using bone graft and collagen barrier
Intervention Type
Dietary Supplement
Intervention Name(s)
locally injected vitamin D
Other Intervention Name(s)
non-surgical periodontal rgeneration
Intervention Description
locally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects
Primary Outcome Measure Information:
Title
radiographic interproximal bone level
Description
radiographic interproximal bone level
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with infrabony vertical defects
systemically free patients
periodontally affected patients
Exclusion Criteria:
patients with systemic diseases
smokers
pregnency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nermin yussif
Organizational Affiliation
october university of modern sciences and arts
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects
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