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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04731545
• Collaborator: Institut Straumann AG (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 46.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dental Implant; Immediate Implant	Device: immediate implant placement	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT
• Actual Study Start Date: Jul 15, 2018
• Actual Primary Completion Date: Jul 1, 2021
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

3. Soft tissue thickness [3 months]

   Periodontal probe

4. Post operative pain and swelling [1 week]

   Blinded assessment ( numerical score)

5. Buccal bone thickness [3 months]

   Cone Beam Computed Topography

6. Postsurgical satisfaction [1 week]

   Questionnaire

7. Pink aesthetic score [12 months post loading]

   Pink esthetic score Scale 0 being the lowest and 14 highest attainable

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.,

1. Good oral hygiene.

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Oral and Dental Medicine Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Cairo University
• Institut Straumann AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hani Elnahass, Assitant Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04731545
• Other Study ID Numbers: 333
• First Posted: Feb 1, 2021
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Hani Elnahass, Assitant Professor, Cairo University: immediate implant; esthetic zone; buccal plate; SLActive
• Additional relevant MeSH terms: Bone Resorption

Study Results

No Results Posted as of Jun 30, 2022