Beta-Tricalcium Phosphate and Concentrated Growth Factors in Treatment of Intra-bony Defect Randomized Clinical Trial (RCT)
Primary Purpose
Chronic Periodontitis, Intrabony Periodontal Defect, Concentrated Growth Factors
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
open flap debridement
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Beta-Tricalcium Phosphate, regeneration, concentrated growth factors
Eligibility Criteria
Inclusion Criteria:
- systemically healthy patients were selected
- patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
- Patients should demonstrate their ability to maintain good oral hygiene
Exclusion Criteria:
- Smokers and pregnant patients.
- Medically compromised patients and systemic conditions precluding periodontal surgery.
- Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
- Sites with tooth mobility
- Restoration or caries in the site to be treated or non-vital tooth
- Restoration or caries in the site to be treated or non-vital tooth
Sites / Locations
- Malak Mohamed Shoukheba
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
beta-tricalcium phosphate plus concentrated growth factors
beta tricalcium phosphate alone(control group)
Arm Description
surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group),
Outcomes
Primary Outcome Measures
gingival index
gingival index will be recorded at baseline, 3, and 6 months at the site to be treated
bleeding on probing
bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
probing pocket depth
probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
clinical attachment level
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring defect area
defect area will be recorded at baseline, and 6 months at the site to be treated
cone beam x ray measuring bone density
bone density will be recorded at baseline, and 6 months at the site to be treated
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04698317
Brief Title
Beta-Tricalcium Phosphate and Concentrated Growth Factors in Treatment of Intra-bony Defect Randomized Clinical Trial
Acronym
RCT
Official Title
Biodegradable Gelatin Sponge Loaded With Beta-Tricalcium Phosphate Sponges Incorporating Concentrated Growth Factors in the Treatment of Intra-bony Pocket Randomized Clinical and Radiographic Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone.
Detailed Description
40 intra-bony defects in 40 patients will be selected from outpatient clinic of Oral Periodontology Clinic Faculty of Dentistry, Tanta University to participate in this study. Each defect had intra-bony depth > or = 4 mm and probing pocket depth (PPD) > or = 6 mm. Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone.
(control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Gingival index (GI), bleeding on probing, Probing pocket depth and clinical attachment level (CAL) will assessed at baseline, 3, and 6 months at the site to be treated. Cone beam radiographs evaluation will be taken at baseline, and 6 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Intrabony Periodontal Defect, Concentrated Growth Factors
Keywords
Beta-Tricalcium Phosphate, regeneration, concentrated growth factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
40 Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone.
(control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
beta-tricalcium phosphate plus concentrated growth factors
Arm Type
Experimental
Arm Description
surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Arm Title
beta tricalcium phosphate alone(control group)
Arm Type
Placebo Comparator
Arm Description
surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group),
Intervention Type
Procedure
Intervention Name(s)
open flap debridement
Other Intervention Name(s)
periodontal surgery
Intervention Description
Open flap for removal of diseased periodontal tissues and necrotic cementum
Intervention Type
Other
Intervention Name(s)
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors
Other Intervention Name(s)
regenerative surgery
Intervention Description
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect
Intervention Type
Other
Intervention Name(s)
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone
Other Intervention Name(s)
Regenerative surgery
Intervention Description
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect
Primary Outcome Measure Information:
Title
gingival index
Description
gingival index will be recorded at baseline, 3, and 6 months at the site to be treated
Time Frame
6months
Title
bleeding on probing
Description
bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
Time Frame
6 months
Title
probing pocket depth
Description
probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
Time Frame
6 months
Title
clinical attachment level
Description
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
Time Frame
6 months
Title
cone beam x ray measuring defect area
Description
defect area will be recorded at baseline, and 6 months at the site to be treated
Time Frame
6 months
Title
cone beam x ray measuring bone density
Description
bone density will be recorded at baseline, and 6 months at the site to be treated
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
systemically healthy patients were selected
patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
Patients should demonstrate their ability to maintain good oral hygiene
Exclusion Criteria:
Smokers and pregnant patients.
Medically compromised patients and systemic conditions precluding periodontal surgery.
Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
Sites with tooth mobility
Restoration or caries in the site to be treated or non-vital tooth
Restoration or caries in the site to be treated or non-vital tooth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
malak m shoukheba
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malak Mohamed Shoukheba
City
Tanta
ZIP/Postal Code
020
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Beta-Tricalcium Phosphate and Concentrated Growth Factors in Treatment of Intra-bony Defect Randomized Clinical Trial
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