Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

NCT ID: NCT05360693

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-04-29

Brief Summary

For the dimension of the peri-implant buccal gap, a controversy is present whether complete bone formation labial to the implant. Therefore, leaving the blood clot in the large socket around implants without augmentation is questionable to result in complete bone fill and would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate the labial bone dimensional changes after immediate implant placement in the esthetic zone with & without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.

Conditions

Immediate Implants; Esthetic Zone; Labial Bone Dimensional Changes; Without Labial Bone Grafting; With Labial Grafting; Thin Labial Plate of Bone Pre-extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

immediate implant placement without bone grafting

After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface.

Group Type: EXPERIMENTAL

immediate implant placement without bone grafting

Intervention Type: PROCEDURE

After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done \& patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.

immediate implant placement with bone grafting

After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface.

Group Type: ACTIVE_COMPARATOR

immediate implant placement with socket bone grafting

Intervention Type: PROCEDURE

After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done and patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). In order to ensure standardization and reproducibility of the CBCT cross sectional images used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.

Interventions

immediate implant placement without bone grafting

After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done \& patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.

Intervention Type: PROCEDURE

immediate implant placement with socket bone grafting

After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done and patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). In order to ensure standardization and reproducibility of the CBCT cross sectional images used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. adult (>20 years) with non-restorable maxillary teeth in the esthetic zone,

2. thick gingival phenotype,

3. intact but thin labial plate of bone (≤1mm)

4. intact palatal bone extending at least 6mm apically,

5. sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)

6. labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5mm.

7. patients agreed to sign a written informed consent.

Exclusion Criteria

1. smokers,

2. pregnant women,

3. patients with systemic disease,

4. patients with parafunctional habits such as bruxism or clenching,

5. infected socket,

6. periapical pathosis

7. history of radiotherapy or chemotherapy within the past 2 years.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Mohamed Fouad Shemais

Lecturer in the department of Oral Medicine & Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha A Ghallab, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Oral Medicine & Periodontology

Ahmed I Abou- El-Fettouh, MSc

Role: STUDY_DIRECTOR

Misr International University

Abdelrahman Zohny, BDs

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Nael M Adel, BDs

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Khaled Abdelghaffar, PhD

Role: STUDY_CHAIR

Professor of Periodontology, Ain Shams University

Mariam S Abdelmalak, BDs

Role: PRINCIPAL_INVESTIGATOR

Misr International University

Nesma M Shemais, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Oral Medicine & Periodontology, Cairo University

Locations

International Dental Continuing Education

Cairo, Maadi, Egypt

Faculty of Dentistry, Cairo University

Cairo, Manial, Egypt

Countries

Egypt

Other Identifiers

IDCE.N1

Identifier Type: -

Identifier Source: org_study_id