Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

Not Applicable

Completed

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

• Registration Number: NCT05360693
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-29
• Study First Submitted: 2022-04-30
• Study First Submitted QC: 2022-04-30
• Study First Posted: 2022-05-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-04
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate implant placement without bone grafting	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.
immediate implant placement with bone grafting	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 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.

Primary Outcome Measures

Name	Time	Method
Amount of bone labial to the implant	1 year	CBCT superimposition (fusion scans)
horizontal labio-palatal bone collapse	1 year	CBCT superimposition (fusion scans)
Horizontal labio-palatal bone width	1 year	CBCT superimposition (fusion scans)
vertical bone dimensional changes	1 year	CBCT superimposition (fusion scans)

Secondary Outcome Measures

Name	Time	Method
Plaque Index	1 year	Plaque index
gingival index	1 year	bleeding on probing around customized healing abutments placed on the immediate implants
Implant failure	1 year	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.
Postoperative Pain	1 day, 3 days, 7 days	VAS

Trial Locations

Locations (2)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Manial, Egypt

International Dental Continuing Education; 🇪🇬 Cairo, Maadi, Egypt