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

NCT05407363 | Completed

• 1 other identifier: KFSIRB200-72
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

ABB and ATG with simultaneous implant placement

EXPERIMENTAL

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

Procedure: ABB and ATG with simultaneous implant placement

XBB and ATG with simultaneous implant placement

EXPERIMENTAL

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

Procedure: XBB and ATG with simultaneous implant placement

ABB and ABG with immediate implant

ACTIVE COMPARATOR

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

Procedure: ABB and ABG with simultaneous implant placement

Interventions

ABB and ATG with simultaneous implant placement PROCEDURE

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

ABB and ATG with simultaneous implant placement

XBB and ATG with simultaneous implant placement PROCEDURE

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

XBB and ATG with simultaneous implant placement

ABB and ABG with simultaneous implant placement PROCEDURE

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

ABB and ABG with immediate implant

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, 33511, Egypt

Location

MeSH Terms

Interventions

Blood Gas Analysis

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Dalia R Issa, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: June 7, 2022
• Study Start: April 1, 2022
• Primary Completion: August 12, 2023
• Study Completion: August 20, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

EG (1)