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

• Sponsor: Kafrelsheikh University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05407363
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10.1
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ridge Augmentation; Implant; Autogenous Tooth Graft	Procedure: ABB and ATG with simultaneous implant placement; Procedure: XBB and ATG with simultaneous implant placement; Procedure: ABB and ABG with simultaneous implant placement	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ridge Augmentation With Simultaneous Implant Placement Using Xenogenic Blocks or Autogenous Bone Blocks With Autogenous Tooth Graft
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABB and ATG with simultaneous implant placement Using ABB with ATG to fill the gap around simultaneously placed dental implants	Procedure: ABB and ATG with simultaneous implant placement; 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	Procedure: XBB and ATG with simultaneous implant placement; 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	Procedure: ABB and ABG with simultaneous implant placement; Ridge augmentation using ABB and ABG as a graft material with simultaneous implant placement

Outcome Measures

Primary Outcome Measures

1. Clinical evaluation probing pocket depth and amount of bone around simultaneously placed dental implants [9 months]

   Changes on pocket depth and amount of bone using ABG or ATG with ABB or XBB around simultaneously placed dental implants

2. radiographic outcome measuring the amount of bone around simultaneously placed dental implants [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Kafrelsheikh University	Kafr Ash Shaykh		Egypt	33511

Sponsors and Collaborators

• Kafrelsheikh University

Investigators

• Principal Investigator: Dalia R Issa, PhD, Kafrelsheikh University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dalia Rasheed Issa, Director, Kafrelsheikh University
• ClinicalTrials.gov Identifier: NCT05407363
• Other Study ID Numbers: KD/26/22
• First Posted: Jun 7, 2022
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 8, 2022