Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06131541
Other study ID # KFSIRB200-80
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05332327 - Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
Enrolling by invitation NCT06063876 - Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty N/A
Completed NCT04249024 - Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery N/A
Withdrawn NCT03624257 - Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery N/A
Completed NCT03018795 - Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis N/A
Completed NCT02375750 - Treatment of Peri-implantitis Lesions by Using Biomaterial N/A
Completed NCT03157193 - Effect of Hyaluronic Acid on Perimplantitis Phase 4
Enrolling by invitation NCT02575274 - Peri-Implantitis Surgical Treatment an RCT Study Phase 2/Phase 3
Completed NCT04833569 - ICG-PDT, Periimplantitis, Diabetes Mellitus Phase 1
Not yet recruiting NCT04337645 - Resective Surgical Treatment of Peri-implantitis. N/A
Enrolling by invitation NCT06033859 - Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
Active, not recruiting NCT06390124 - Reconstructive Therapy of Peri-implantitis With PDGF-BB (Gem-21) Phase 4
Enrolling by invitation NCT05675241 - Characterizing the Inflammation Around Dental Implants
Recruiting NCT04983758 - 20-year Implant Survival in Periodontally Healthy and Compromised Patients
Not yet recruiting NCT04323540 - Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation N/A
Completed NCT04769609 - Reconstructive Surgical Therapy of Peri-implantitis
Completed NCT04874467 - Influence of Keratinized Mucosa on Dental Implants With Mucositis N/A
Completed NCT05724706 - An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
Completed NCT04559841 - Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin N/A
Recruiting NCT05906810 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis N/A