Ridge Splitting With Implant Placement Using Autogenous Tooth Graft

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06131541
• Other study ID #: KFSIRB200-80
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 30, 2023
• Est. primary completion date: November 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• autogenous tooth graft
undemineralized autogenous tooth graft will augment the gap between the splitted ridge and the simultaneously [laced implant fixture
• autogenous bone graft
autogenous bone graft will augment the gap between the splitted ridge and the simultaneously [laced implant fixture

Locations

Country	Name	City	State
Egypt	faculty of dentistry, kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	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