Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

NCT05360693 | Completed

• 1 other identifier: IDCE.N1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• Amount of bone labial to the implant

  CBCT superimposition (fusion scans)

  1 year

• Horizontal labio-palatal bone width

  CBCT superimposition (fusion scans)

  1 year

• horizontal labio-palatal bone collapse

  CBCT superimposition (fusion scans)

  1 year

• vertical bone dimensional changes

  CBCT superimposition (fusion scans)

  1 year

Secondary Outcomes (4)

• gingival index

  1 year

• Implant failure

  1 year

• Plaque Index

  1 year

• Postoperative Pain

  1 day, 3 days, 7 days

Study Arms (2)

immediate implant placement without bone grafting

EXPERIMENTAL

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.

Procedure: immediate implant placement without bone grafting

immediate implant placement with bone grafting

ACTIVE COMPARATOR

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.

Procedure: immediate implant placement with socket bone grafting

Interventions

immediate implant placement without bone grafting 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 without bone grafting

immediate implant placement with socket bone grafting 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.

immediate implant placement with bone grafting

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult (\>20 years) with non-restorable maxillary teeth in the esthetic zone,
• thick gingival phenotype,
• intact but thin labial plate of bone (≤1mm)
• intact palatal bone extending at least 6mm apically,
• sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)
• labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5mm.
• patients agreed to sign a written informed consent.

You may not qualify if:

• smokers,
• pregnant women,
• patients with systemic disease,
• patients with parafunctional habits such as bruxism or clenching,
• infected socket,
• periapical pathosis
• history of radiotherapy or chemotherapy within the past 2 years.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

International Dental Continuing Education

Cairo, Maadi, 11728, Egypt

Location

Faculty of Dentistry, Cairo University

Cairo, Manial, 35855, Egypt

Location

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Noha A Ghallab, PhD

  Professor of Oral Medicine & Periodontology

  PRINCIPAL INVESTIGATOR

• Ahmed I Abou- El-Fettouh, MSc

  Misr International University

  STUDY DIRECTOR

• Abdelrahman Zohny, BDs

  Misr International University

  PRINCIPAL INVESTIGATOR

• Nael M Adel, BDs

  Misr International University

  PRINCIPAL INVESTIGATOR

• Khaled Abdelghaffar, PhD

  Professor of Periodontology, Ain Shams University

  STUDY CHAIR

• Mariam S Abdelmalak, BDs

  Misr International University

  PRINCIPAL INVESTIGATOR

• Nesma M Shemais, PhD

  Lecturer of Oral Medicine & Periodontology, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in the department of Oral Medicine & Periodontology

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 4, 2022
• Study Start: November 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 29, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)