Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation
Primary Purpose
Alveolar Bone Loss
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Alveolar ridge preservation using whole-tooth dentin graft
Alveolar ridge preservation using particulate dentin graft
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
Inclusion Criteria:
- Non-restorable tooth indicated for extraction
- single-rooted teeth
- Patients at least 18 years or older
- Motivated patients, agree to sign informed consent and complete the follow-up period
Exclusion Criteria:
- Pregnant females
- active infection at extraction site
- Smokers
- systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole-tooth dentin graft
Particulate dentin graft
Arm Description
The extracted tooth will be prepared as whole-tooth dentin graft and inserted in the extraction socket.
The extracted tooth will be prepared as particulate dentin graft and inserted in the extraction socket.
Outcomes
Primary Outcome Measures
Alveolar bone width change in mm
Alveolar bone linear width will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be expressed in millimetres.
Secondary Outcome Measures
Alveolar bone height change in mm
Alveolar bone linear height will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone height will be calculated as the subtraction of final height from baseline height and will be expressed in millimetres.
Histological assessment
Bone samples from at least one control and one intervention site will be taken during implant placement using a trephine bur. Samples will be examined for new bone formation (Yes/no) and inflammatory response (Yes/no).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05336149
Brief Title
Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation
Official Title
Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation. a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
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
5. Study Description
Brief Summary
The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation.
Detailed Description
Extraction of the teeth is still one of the most commonly undertaken procedures in dental practices due to various reasons that render the teeth non-restorable. Following extraction, replacing the lost teeth with a prosthetic alternative that provides for both optimal esthetics and function can be challenging due to the inevitable events of socket healing that results in the reduction in alveolar bone height and width. To overcome these limitations and provide for adequate ridge volume, different bone preservation or augmentation techniques can be utilized with different clinical applications.
Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. To overcome this problem, various approaches using various grafting materials and/or covering membranes have been proposed with varied success. The extracted tooth is no longer considered as clinical waste, it has been explored as an appropriate source for autogenous graft substitute. This idea emerged due to the shared embryonic origin of bone and teeth as well as the similarities in chemical structure as dentin is composed of 30-35% organic part and 65-70% inorganic part in comparison to alveolar bone, with inorganic and organic parts of 35% and 65% respectively. Both whole-tooth and particulate forms has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole-tooth dentin graft
Arm Type
Experimental
Arm Description
The extracted tooth will be prepared as whole-tooth dentin graft and inserted in the extraction socket.
Arm Title
Particulate dentin graft
Arm Type
Active Comparator
Arm Description
The extracted tooth will be prepared as particulate dentin graft and inserted in the extraction socket.
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge preservation using whole-tooth dentin graft
Intervention Description
Minimally-traumatic extraction of non-restorable teeth then grafting with whole-tooth dentin graft
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge preservation using particulate dentin graft
Intervention Description
Minimally-traumatic extraction of non-restorable teeth then grafting with particulate dentin graft
Primary Outcome Measure Information:
Title
Alveolar bone width change in mm
Description
Alveolar bone linear width will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be expressed in millimetres.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Alveolar bone height change in mm
Description
Alveolar bone linear height will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone height will be calculated as the subtraction of final height from baseline height and will be expressed in millimetres.
Time Frame
6 months
Title
Histological assessment
Description
Bone samples from at least one control and one intervention site will be taken during implant placement using a trephine bur. Samples will be examined for new bone formation (Yes/no) and inflammatory response (Yes/no).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Non-restorable tooth indicated for extraction
single-rooted teeth
Patients at least 18 years or older
Motivated patients, agree to sign informed consent and complete the follow-up period
Exclusion Criteria:
Pregnant females
active infection at extraction site
Smokers
systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Elfana, MSc
Phone
+2223634965
Email
ahmed.abdelraouf@dentistry.cu.edu.eg
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation
We'll reach out to this number within 24 hrs