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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05407363
Other study ID # KFSIRB200-72
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date August 20, 2023

Study information

Verified date December 2023
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 20, 2023
Est. primary completion date August 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
ABB and ATG with simultaneous implant placement
Ridge augmentation using ABB and ATG as a graft material with simultaneous implant placement
XBB and ATG with simultaneous implant placement
Ridge augmentation using XBB and ATG as a graft material with simultaneous implant placement
ABB and ABG with simultaneous implant placement
Ridge augmentation using ABB and ABG as a graft material with simultaneous implant placement

Locations

Country Name City State
Egypt Faculty of Dentistry, Kafrelsheikh University Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical evaluation probing pocket depth and amount of bone around simultaneously placed dental implants Changes on pocket depth and amount of bone using ABG or ATG with ABB or XBB around simultaneously placed dental implants 9 months
Primary radiographic outcome measuring the amount of bone around simultaneously placed dental implants 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
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