Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

Evaluation of Horizontal and Vertical Labial Bone Dimensional Changes After Flapless Immediate Implant Placement With and Without Bone Grafting: A 1-year Cone-beam Computed Tomography Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Immediate Implants; Esthetic Zone; Labial Bone Dimensional Changes; Without Labial Bone Grafting; With Labial Grafting; Thin Labial Plate of Bone Pre-extraction
• Intervention / Treatment: Procedure: immediate implant placement without bone grafting; Procedure: immediate implant placement with socket bone grafting

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Maadi
    • Cairo, Maadi, Egypt, 11728
      • International Dental Continuing Education
  • Manial
    • Cairo, Manial, Egypt, 35855
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival index	bleeding on probing around customized healing abutments placed on the immediate implants	1 year
Implant failure	The following are the criteria of the implant success: the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ≧ 5 mm, and without vertical bone loss ≧ 1.5 mm in the first year. The cases will be defined as failure if it can't reach any one of the success criteria.	1 year
Plaque Index	Plaque index	1 year
Postoperative Pain	VAS	1 day, 3 days, 7 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Noha A Ghallab, PhD, Professor of Oral Medicine & Periodontology; Study Director: Ahmed I Abou- El-Fettouh, MSc, Misr International University; Principal Investigator: Abdelrahman Zohny, BDs, Misr International University; Principal Investigator: Nael M Adel, BDs, Misr International University; Study Chair: Khaled Abdelghaffar, PhD, Professor of Periodontology, Ain Shams University; Principal Investigator: Mariam S Abdelmalak, BDs, Misr International University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: April 30, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 4, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IDCE.N1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No