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

Primary Purpose

Dental Implant, Immediate Implant

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
immediate implant placement
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implant focused on measuring immediate implant, esthetic zone, buccal plate, SLActive

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Oral and Dental Medicine Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

thin buccal bone

thick buccal bone

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Soft tissue thickness
Periodontal probe
Post operative pain and swelling
Blinded assessment ( numerical score)
Buccal bone thickness
Cone Beam Computed Topography
Postsurgical satisfaction
Questionnaire
Pink aesthetic score
Pink esthetic score Scale 0 being the lowest and 14 highest attainable

Full Information

First Posted
January 25, 2021
Last Updated
June 29, 2022
Sponsor
Cairo University
Collaborators
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT04731545
Brief Title
Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone
Official Title
Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Institut Straumann AG

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant, Immediate Implant
Keywords
immediate implant, esthetic zone, buccal plate, SLActive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thin buccal bone
Arm Type
Active Comparator
Arm Title
thick buccal bone
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
immediate implant placement
Intervention Description
Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.
Primary Outcome Measure Information:
Title
Bucccal bone changes
Description
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
Time Frame
12 months post loading
Secondary Outcome Measure Information:
Title
Implant stability
Description
Ostell readings in isq (range from 55 till over 70) bleow 55 low stability over 55 till 65 moderate stability above 70 good stability
Time Frame
3 months
Title
Crestal bone changes
Description
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.
Time Frame
12 months post loading
Title
Soft tissue thickness
Description
Periodontal probe
Time Frame
3 months
Title
Post operative pain and swelling
Description
Blinded assessment ( numerical score)
Time Frame
1 week
Title
Buccal bone thickness
Description
Cone Beam Computed Topography
Time Frame
3 months
Title
Postsurgical satisfaction
Description
Questionnaire
Time Frame
1 week
Title
Pink aesthetic score
Description
Pink esthetic score Scale 0 being the lowest and 14 highest attainable
Time Frame
12 months post loading

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Single bounded irrestorable tooth in the esthetic zone that needs to be extracted. Healthy systemic condition. Type I socket with a minimum of 1mm of buccal bone thickness prior to extraction. (Morton et al., 2014) Sufficient bone apical to the socket for implant primary stability. (Morton et al., 2014) Good oral hygiene. Patient accepts a minimum of three-year follow-up period (cooperative patients). Exclusion Criteria: Signs of acute infection related to the area of interest. Patients with parafunctional habits (Lobbezoo et al. 2006 and Roelhing et al. 2016). Smokers (Lambert et al. 2000). Pregnant females.
Facility Information:
Facility Name
Faculty of Oral and Dental Medicine Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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