Ridge Splitting With Implant Placement Using Autogenous Tooth Graft

Alveolar Ridge Splitting With Simultaneous Implant Placement Using Undemineralized Autogenous Tooth Graft: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis; Alveolar Bone Loss; Dental Implant Failure Nos
• Intervention / Treatment: Procedure: autogenous bone graft; Procedure: autogenous tooth graft

Detailed Description

In cases of a narrow ridge, the alveolar ridge expansion technique by means of hand osteotomes with gradually increasing dimensions was introduced by Tatum and modified by Summers and it can be used regardless of the bone quality.

Searching for absolute biocompatible material and taking into account the features of the enamel and dentin, using the tooth as an autologous grafting material was first advocated. Tooth and bone are sharing many characteristics, which supports the idea that tooth could be used as a grafting material. In fact, hydroxyapatite crystals make up the tooth inorganic composition (65%). Moreover, Collagen (mostly type I) and non-collagenic proteins comprised up the tooth organic component (35%). In addition, because autologous tooth graft (ATG) is denser than bone, minimal resorption rates were found to be advantageous to autobone. For the purpose of employing ATG as a grafting material, various methods and techniques have been suggested for developing undemineralized, demineralized or partially demineralized ATG.The outcomes of utilizing undemineralized autologous tooth graft (UATG) around SDIP following RSEA have not yet been evaluated. Therefore, the current trial aimed to assess the clinical and radiological performances of UATG for the treatment of horizontal alveolar ridge deficiencies using RSEA with SDIP.

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 214312
      • faculty of dentistry, kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I: autogenous bone graft group; 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; autogenous bone graft will augment the gap between the splitted ridge and the simultaneously [laced implant fixture
Experimental: Group II: autogenous tooth graft group; 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; undemineralized autogenous tooth graft will augment the gap between the splitted ridge and the simultaneously [laced implant fixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink esthetic score (PES)	Digital intraoral scannings were gathered before surgery, at 6 and 12-months after implantation, to evaluate the PES changes. Seven variables were assessed in relation to a nearby reference teeth: mesial and distal papilla, soft tissue level, colour, texture and shape, and alveolar bone defects. 14 is the maximum possible value for PES. Scoring each parameter on a 0-2 scale: 0 is the minimum score and 2 is the maximum.	12 months

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: WAlid AH Elamrousy, Ph.D, Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ridge splitting; Autogenous Tooth Graft; simultaneous implant placement
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss; Peri-Implantitis
• Other Study ID Numbers: KFSIRB200-80

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No