Ridge Splitting With Implant Placement Using Autogenous Tooth Graft

NCT06131541 | Completed DMC

• 1 other identifier: KFSIRB200-80
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the radiographic and the clinical outcomes of application of the alveolar ridge splitting (ARS) in combination with ATG, associated with immediate implant placement versus ARS in combination with autogenous bone graft, associated with immediate implant placement in patients with horizontal bony insufficiency of alveolar ridges.

Conditions

Dental Implant Failure Nos; Alveolar Bone Loss; Peri-Implantitis

Keywords

Ridge splitting; Autogenous Tooth Graft; simultaneous implant placement

Outcome Measures

Primary Outcomes (3)

• Stability Quotient of Implants (SQI)

  The implant stability was recorded using Osstell TM. Following implant insertion, SQI readings were taken immediately, then again after six and twelve months.

  12-month.

• Horizontal bone dimensions (HBDs)

  The HBD alterations were assessed by measuring horizontal spacing between the external edges of labial and palatal bony plates at a level 2mm apical of the fixture platform.

  12 months

• Peri-implant Bone Density (PBD)

  For consistent measurement of the PBD, 1-mm-diameter Region of interest (RI) was selected and traced 1.2 mm distant from the fixture on the cross-sectional slices followed by counting the threshold pixels inside the RI.

  12 months

Secondary Outcomes (1)

• Pink esthetic score (PES)

  12 months

Study Arms (2)

Group I: autogenous bone graft group

EXPERIMENTAL

11 subjects will be assigned to receive alveolar ridge splitting in combination with autogenous bone graft associated with immediate implant placement

Procedure: autogenous bone graft

Group II: autogenous tooth graft group

EXPERIMENTAL

11 subjects will be assigned to receive alveolar ridge splitting in combination with undemineralized autogenous tooth graft associated with immediate implant placement

Procedure: autogenous tooth graft

Interventions

autogenous tooth graft PROCEDURE

undemineralized autogenous tooth graft will augment the gap between the splitted ridge and the simultaneously \[laced implant fixture

Group II: autogenous tooth graft group

autogenous bone graft PROCEDURE

autogenous bone graft will augment the gap between the splitted ridge and the simultaneously \[laced implant fixture

Group I: autogenous bone graft group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health at the time of surgery
• At least 3 months of healing after tooth extraction
• Horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.

You may not qualify if:

• A vertical bone defect in the edentulous ridge;
• Thick cortex in the labial/buccal with less cancellous bone inside;
• Obvious undercut on the labial/buccal side;
• Uncontrolled periodontal conditions or other oral disorders;
• A history of radiotherapy in the head and neck region

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss; Peri-Implantitis

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• WAlid AH Elamrousy, Ph.D

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The present clinical trial was single-blinded one as the evaluator and the statistician were both blinded. While both the implantologist or the participant were not blinded as the interventions were dissimilar.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of periodontology

Model Details: single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 15, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 15, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)