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

Dental Implant Clinical Trial

Official title:

Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731545
• Other study ID #: 333
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Resorption
• Dental Implant
• Immediate Implant

Intervention

Device:
• immediate implant placement
Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine Cairo University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Institut Straumann AG

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bucccal bone changes	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	12 months post loading
Secondary	Implant stability	Ostell readings in isq (range from 55 till over 70) bleow 55 low stability over 55 till 65 moderate stability above 70 good stability	3 months
Secondary	Crestal bone changes	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.	12 months post loading
Secondary	Soft tissue thickness	Periodontal probe	3 months
Secondary	Post operative pain and swelling	Blinded assessment ( numerical score)	1 week
Secondary	Buccal bone thickness	Cone Beam Computed Topography	3 months
Secondary	Postsurgical satisfaction	Questionnaire	1 week
Secondary	Pink aesthetic score	Pink esthetic score Scale 0 being the lowest and 14 highest attainable	12 months post loading