Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone

Not Applicable

Completed

• Conditions: Dental Implant; Immediate Implant
• Interventions: Device: immediate implant placement

• Registration Number: NCT04731545
• Lead Sponsor: Cairo University

Brief Summary

The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone

Detailed Description

With the increased demand for aesthetics and the expectation of immediate tooth replacement, improving the treatment options in case with hopeless teeth in the esthetic zone by immediate implants is a need by both practitioners and patients.

Current guidelines, today, restricting such treatment to only thick (+ or = 1mm) buccal bone plates. However, the literature shows that less than 10% of the community have such criteria, making it a high risk but needed procedure.

Soft tissue and bone remodelling after extraction is an inescapable fact. Immediate implant placement cannot prevent soft tissue and bone remodeling around implants (Araújo et al. 2005, Chen et al. 2009), but implant surface treatment and modifications might enhance the maintainability of the supporting structures around the dental implant due to its faster integration, better stimulating the vascular components at the site. This could be tested by the crestal and buccal bone changes, pink esthetic score and ostell readings.

Study Timeline

• Study Start: 2017-01-15
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Single bounded irrestorable tooth in the esthetic zone that needs to be extracted.
2. Healthy systemic condition.
3. Type I socket with a minimum of 1mm of buccal bone thickness prior to extraction. (Morton et al., 2014)
4. Sufficient bone apical to the socket for implant primary stability. (Morton et al., 2014)
5. Good oral hygiene.
6. Patient accepts a minimum of three-year follow-up period (cooperative patients).

Exclusion Criteria

1. Signs of acute infection related to the area of interest.
2. Patients with parafunctional habits (Lobbezoo et al. 2006 and Roelhing et al. 2016).
3. Smokers (Lambert et al. 2000).
4. Pregnant females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thick buccal bone	immediate implant placement	-
thin buccal bone	immediate implant placement	-

Primary Outcome Measures

Name	Time	Method
Bucccal bone changes	12 months post loading	standardized Cone beam computed Tomography The radiograph will be taken preoperatively and 12 month after. The pre and post operative cone beams will be compared to each other observing any changes of the buccal bone at 2 , 4 and 6 mm from the crest, the measurements will be in mm

Secondary Outcome Measures

Name	Time	Method
Crestal bone changes	12 months post loading	Periapical radiograph the measurements will be taken from the platform of the implants. 3 readings will be taken one at the paltform one above and one below according to pattern and form of the resorption.
Soft tissue thickness	3 months	Periodontal probe
Post operative pain and swelling	1 week	Blinded assessment ( numerical score)
Pink aesthetic score	12 months post loading	Pink esthetic score Scale 0 being the lowest and 14 highest attainable
Buccal bone thickness	3 months	Cone Beam Computed Topography
Postsurgical satisfaction	1 week	Questionnaire
Implant stability	3 months	Ostell readings in isq (range from 55 till over 70) bleow 55 low stability over 55 till 65 moderate stability above 70 good stability

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine Cairo University; 🇪🇬 Cairo, Egypt