Clinical trial NCT06131541: Ridge Splitting With Implant Placement Using Autogenous Tooth Graft
Official title: Alveolar Ridge Splitting With Simultaneous Implant Placement Using Undemineralized Autogenous Tooth Graft: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Failure Nos
Alveolar Bone Loss
Peri-Implantitis
Keywords: Ridge splitting
Autogenous Tooth Graft
simultaneous implant placement
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, prospective, single-blinded, randomized parallel two-arm controlled clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stability Quotient of Implants (SQI)
timeFrame: 12-month.
measure: Horizontal bone dimensions (HBDs)
timeFrame: 12 months
measure: Peri-implant Bone Density (PBD)
timeFrame: 12 months
Secondary outcomes:
measure: Pink esthetic score (PES)
timeFrame: 12 months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: faculty of dentistry, kafrelsheikh University
state: Kafrelsheikh
Study officials:
affiliation: Kafrelsheikh University
name: WAlid AH Elamrousy, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: