Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

Esthetic Zone Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360693
• Other study ID #: IDCE.N1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: April 29, 2022

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 29, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Implants

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	Manial
Egypt	International Dental Continuing Education	Cairo	Maadi

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of bone labial to the implant	CBCT superimposition (fusion scans)	1 year
Primary	Horizontal labio-palatal bone width	CBCT superimposition (fusion scans)	1 year
Primary	horizontal labio-palatal bone collapse	CBCT superimposition (fusion scans)	1 year
Primary	vertical bone dimensional changes	CBCT superimposition (fusion scans)	1 year
Secondary	gingival index	bleeding on probing around customized healing abutments placed on the immediate implants	1 year
Secondary	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
Secondary	Plaque Index	Plaque index	1 year
Secondary	Postoperative Pain	VAS	1 day, 3 days, 7 days