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

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

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

Study Overview

• Status: Completed
• Conditions: Dental Implant; Immediate Implant
• Intervention / Treatment: Device: immediate implant placement

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Oral and Dental Medicine Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: thin buccal bone	Device: immediate implant placement; Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.
Active Comparator: thick buccal bone	Device: immediate implant placement; Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Soft tissue thickness	Periodontal probe	3 months
Post operative pain and swelling	Blinded assessment ( numerical score)	1 week
Buccal bone thickness	Cone Beam Computed Topography	3 months
Postsurgical satisfaction	Questionnaire	1 week
Pink aesthetic score	Pink esthetic score Scale 0 being the lowest and 14 highest attainable	12 months post loading

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Institut Straumann AG

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: immediate implant; esthetic zone; buccal plate; SLActive
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: 333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No