Ridge Augmentation With Simultaneous Implant Placement Using Bone Blocks With Autogenous Tooth Graft

NCT ID: NCT05407363

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-08-20

Brief 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.

Conditions

Ridge Augmentation; Implant; Autogenous Tooth Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ABB and ATG with simultaneous implant placement

Using ABB with ATG to fill the gap around simultaneously placed dental implants

Group Type: EXPERIMENTAL

ABB and ATG with simultaneous implant placement

Intervention Type: PROCEDURE

Ridge augmentation using ABB and ATG as a graft material with simultaneous implant placement

XBB and ATG with simultaneous implant placement

Using XBB with ATG to fill the gap around simultaneously placed dental implants

Group Type: EXPERIMENTAL

XBB and ATG with simultaneous implant placement

Intervention Type: PROCEDURE

Ridge augmentation using XBB and ATG as a graft material with simultaneous implant placement

ABB and ABG with immediate implant

Using ABB with ABG to fill the gap around immediately placed dental implants

Group Type: ACTIVE_COMPARATOR

ABB and ABG with simultaneous implant placement

Intervention Type: PROCEDURE

Ridge augmentation using ABB and ABG as a graft material with simultaneous implant placement

Interventions

ABB and ATG with simultaneous implant placement

Ridge augmentation using ABB and ATG as a graft material with simultaneous implant placement

Intervention Type: PROCEDURE

XBB and ATG with simultaneous implant placement

Ridge augmentation using XBB and ATG as a graft material with simultaneous implant placement

Intervention Type: PROCEDURE

ABB and ABG with simultaneous implant placement

Ridge augmentation using ABB and ABG as a graft material with simultaneous implant placement

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Dalia Rasheed Issa

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dalia R Issa, PhD

Role: PRINCIPAL_INVESTIGATOR

Kafrelsheikh University

Locations

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, , Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-72

Identifier Type: -

Identifier Source: org_study_id