Ridge Splitting With Implant Placement Using Autogenous Tooth Graft

Sponsor

Kafrelsheikh University (Other)

Overall Status

Completed

CT.gov ID

NCT06131541

Collaborator

(none)

Enrollment

Location

Arms

14.8

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implant Failure Nos Alveolar Bone Loss Peri-Implantitis	Procedure: autogenous tooth graft Procedure: autogenous bone graft	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trialsingle-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 13, 2022

Actual Primary Completion Date :

Sep 12, 2023

Actual Study Completion Date :

Nov 5, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Stability Quotient of Implants (SQI) [12-month.]
The implant stability was recorded using Osstell TM. Following implant insertion, SQI readings were taken immediately, then again after six and twelve months.
Horizontal bone dimensions (HBDs) [12 months]
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.
Peri-implant Bone Density (PBD) [12 months]
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.

Secondary Outcome Measures

Pink esthetic score (PES) [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of dentistry, kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh	Egypt	214312

Sponsors and Collaborators

Kafrelsheikh University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Walid Elamrousy, Assistant Professor of periodontology, Kafrelsheikh University

ClinicalTrials.gov Identifier:

NCT06131541

Other Study ID Numbers:

KFSIRB200-80

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Walid Elamrousy, Assistant Professor of periodontology, Kafrelsheikh University

Ridge splitting

Autogenous Tooth Graft

simultaneous implant placement

Additional relevant MeSH terms:

Alveolar Bone Loss

Peri-Implantitis

Study Results

No Results Posted as of Nov 21, 2023