Back to resultsAlveolar Ridge Preservation Using Different Bone Substitutes
Primary Purpose
Alveolar Ridge Enlargement
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Toothgraft
Allograft
Alloplast
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Ridge Enlargement focused on measuring Alveolar ridge preservation, Allograft, Toothgraft, Allopast
Eligibility Criteria
Inclusion Criteria: seeking implant-based restorations after tooth extraction. exhibited no evidence of any significant medical history, measured using Burket's Oral medicine health history questionnaire. exhibited Type I and II sockets Exclusion Criteria: nonsmokers. Pregnant and breast-feeding females patients with known contraindications to dental implant surgery (e.g., increased bleeding tendency, history of treatments such as radiotherapy,
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Alveolar ridge preservationwith tooth graft
Alveolar ridge preservation with allograft
Alveolar ridge preservation with alloplast
Arm Description
tooth graft
Allograft
Beta Tri-Calcium phosphate
Outcomes
Primary Outcome Measures
Clinical assessment
Measure bone height loss in millimeter at baseline and after 3 months was measured using periodontal probe from the stent margin to the alveolar ridge crest at six points. In addition, Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.
Clinical assessment
Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.
Secondary Outcome Measures
Radiographic assessment
Measuring loss in bone height in millimeters between baseline and after 3 months. Loss in bone height was calculated by measuring the distance from the alveolar crest both buccally and palatally to a fixed anatomical landmark. In addition,
Radiographic assessment
Loss in bone width was calculated by measuring distance from buccal alveolar crest to palatal alveolar crest in millimeter.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05812872
Brief Title
Alveolar Ridge Preservation Using Different Bone Substitutes
Official Title
The Effect of Allograft, Toothgraft, Alloplast on Alveolar Ridge Preservation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
September 23, 2018 (Actual)
Study Completion Date
January 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams 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
The primary objective of this study was to compare the efficacy of using allograft, autogenous tooth graft, and beta-tricalcium phosphate for alveolar ridge preservation (ARP) by examining the alveolar ridge height and width at baseline and 3 months after the ARP both clinically and radiographically. The secondary objective was to evaluate the quality of the newly formed bone using histomorphometric analysis.
Detailed Description
This randomized controlled clinical trial included thirty patients. ARP was performed using either Allograft (Allograft group n=10), Tooth graft (Toothgraft group n=10), and beta tri-calcium- phosphate (beta tri-calcium group n=10). Changes in alveolar ridge dimensions were evaluated clinically and radiographically using cone beam computed tomography at baseline and 3 months. Core bone biopsy samples were obtained 3 months post-extraction during implant placement for histomorphometric analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Ridge Enlargement
Keywords
Alveolar ridge preservation, Allograft, Toothgraft, Allopast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alveolar ridge preservationwith tooth graft
Arm Type
Active Comparator
Arm Description
tooth graft
Arm Title
Alveolar ridge preservation with allograft
Arm Type
Active Comparator
Arm Description
Allograft
Arm Title
Alveolar ridge preservation with alloplast
Arm Type
Active Comparator
Arm Description
Beta Tri-Calcium phosphate
Intervention Type
Drug
Intervention Name(s)
Toothgraft
Intervention Description
Particulate dentin
Intervention Type
Drug
Intervention Name(s)
Allograft
Other Intervention Name(s)
Mineralized corticocancellous allograft
Intervention Description
Mineralized corticocancellous allograft
Intervention Type
Drug
Intervention Name(s)
Alloplast
Other Intervention Name(s)
Beta tri-calcuim phosphate
Intervention Description
Beta tri-calcuim phosphate
Primary Outcome Measure Information:
Title
Clinical assessment
Description
Measure bone height loss in millimeter at baseline and after 3 months was measured using periodontal probe from the stent margin to the alveolar ridge crest at six points. In addition, Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.
Time Frame
3 months
Title
Clinical assessment
Description
Bone width loss was calculated by measuring alveolar ridge width buccopalatally in millimeter using a caliper clamp. The measurement was done perpendicular to the tangent of the dental arch at the mid-point of the extraction site approximately 4mm apical to the level of the marginal gingiva of the adjacent teeth.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Radiographic assessment
Description
Measuring loss in bone height in millimeters between baseline and after 3 months. Loss in bone height was calculated by measuring the distance from the alveolar crest both buccally and palatally to a fixed anatomical landmark. In addition,
Time Frame
3 months
Title
Radiographic assessment
Description
Loss in bone width was calculated by measuring distance from buccal alveolar crest to palatal alveolar crest in millimeter.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Histological
Description
Masson trichrome special stain was used to detect the area percentage of immature collagen and mature collagen at magnification 20X. The immature collagen appeared blue in color while areas with mature collagen appeared reddish in color
Time Frame
3 months
Title
Histomorphometric analysis
Description
Photomicrographs of 3 microscopic fields of each MT stained section, were captured at the original magnification of 20X using a digital camera(Canon EOS 650D) mounted on a light microscope(BX60,Olympus , Japan). The images were analyzed for obtaining the area percentage of mature and immature collagen of the newly formed bone using image J (1.41aNIH, USA)software
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
seeking implant-based restorations after tooth extraction.
exhibited no evidence of any significant medical history, measured using Burket's Oral medicine health history questionnaire.
exhibited Type I and II sockets
Exclusion Criteria:
nonsmokers.
Pregnant and breast-feeding females
patients with known contraindications to dental implant surgery (e.g., increased bleeding tendency, history of treatments such as radiotherapy,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasmine A Fouad, Ph.D
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzan M Sarhan, Ph.D
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hadeel M Gamal, Ph.D
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Basma A Abdelrahman, Ph.D
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11751
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Alveolar Ridge Preservation Using Different Bone Substitutes
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