- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407363
Ridge Augmentation With Simultaneous Implant Placement Using Bone Blocks With Autogenous Tooth Graft
Ridge Augmentation With Simultaneous Implant Placement Using Xenogenic Blocks or Autogenous Bone Blocks With Autogenous Tooth Graft
Autogenous bone, with its osteogenic, osteoinductive, and osteo-conductive characteristics has been used for bone grafts with optimal integration into host tissues. For this reason, autogenous bone has been often considered the gold standard of bone regeneration material. However, the amount of autogenous bone that may be harvested is limited, and the harvesting procedure is traumatic.
Bone substitutes, including allografts, xenografts, and alloplasts have been used successfully as alternatives to autogenous bone grafts in ridge augmentation procedures.
In 2008, autogenous tooth bone graft (ATG) was introduced and used for the first time as a bone grafting material for GBR. The tooth contents are extremely similar to that of the alveolar bone. The enamel inorganic, organic, and water contents are 95 percent, 0.6 percent, and 4 percent, respectively. However, in the dentin, the percentages are 70 to 75 percent, 20 percent, and 10 percent, respectively. They are 65 percent, 25 percent, and 10 percent, respectively, when compared to the alveolar bone content.
The aim of this study is to compare ridge augmentation using autogenous bone block (ABB) with immediate implant placement and filling the generated gap with autogenous bone graft (ABG) or ATG, or ridge augmentation using xenograft bone block (XBB) with immediate implant placement and filling the generated gap with ATG.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kafr Ash Shaykh, Egypt, 33511
- faculty of dentistry, kafrelsheikh University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Teeth with buccal bone destruction by periodontal disease and need extraction (horizontal or vertical bone defect);
- Absence of acute inflammation;
- Absence of uncontrolled systemic illness that would preclude implantation;
- Good dental and systemic healthy conditions;
- Patients were willing and able to return for multiple follow-up visits.
Exclusion Criteria:
- Patients with systemic illnesses,
- psychological abnormalities,
- para-functional habit,
- smokers or alcoholics,
- pregnant and lactating patients,
- patients undergoing or recently completed radiotherapy or chemotherapy,
- patients on drugs affecting the healing process,
- patients with endodontically treated teeth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ABB and ATG with simultaneous implant placement
Using ABB with ATG to fill the gap around simultaneously placed dental implants
|
Ridge augmentation using ABB and ATG as a graft material with simultaneous implant placement
|
|
Experimental: XBB and ATG with simultaneous implant placement
Using XBB with ATG to fill the gap around simultaneously placed dental implants
|
Ridge augmentation using XBB and ATG as a graft material with simultaneous implant placement
|
|
Active Comparator: ABB and ABG with immediate implant
Using ABB with ABG to fill the gap around immediately placed dental implants
|
Ridge augmentation using ABB and ABG as a graft material with simultaneous implant placement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical evaluation probing pocket depth and amount of bone around simultaneously placed dental implants
Time Frame: 9 months
|
Changes on pocket depth and amount of bone using ABG or ATG with ABB or XBB around simultaneously placed dental implants
|
9 months
|
|
radiographic outcome measuring the amount of bone around simultaneously placed dental implants
Time Frame: 9 months
|
the radiographic outcome by measuring the amount of bone by using ATG or ABG on bone formation with ABB or XBB around simultaneously placed dental implants
|
9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KFSIRB200-72
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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