Socket Shield Technique With or Without Flap Elevation
Clinical and Radiographic Evaluation of Socket Shield Technique With or Without Flap Elevation
1 other identifier
interventional
12
1 country
1
Brief Summary
It is aimed to compare the bone changes and the amount of marginal bone loss after prosthetic loading around the immediately placed implants using the Socket Shield Technique with or without flap elevation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2019
CompletedFirst Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2024
CompletedDecember 30, 2024
October 1, 2023
4.4 years
August 3, 2022
December 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline marginal bone loss at 12 months
Measurement of marginal bone loss change between baseline and 12th month by cone beam computed tomography
Baseline, 12th month
Secondary Outcomes (10)
Change of peri-implant pocket depth between baseline and follow-up periods
Baseline, 1st month, 3rd month, 6th month, 12th month
Change of modified plaque index between baseline and follow-up periods
Baseline, 1st month, 3rd month, 6th month, 12th month
Change of modified bleeding index between baseline and follow-up periods
Baseline, 1st month, 3rd month, 6th month, 12th month
Change in the width of keratinized mucosa between follow-up periods
Baseline, 1st month, 3rd month, 6th month, 12th month
Change in the mucosal recession between follow-up periods
Baseline, 1st month, 3rd month, 6th month, 12th month
- +5 more secondary outcomes
Study Arms (2)
Flapless Surgery
ACTIVE COMPARATORSurgery With Flap Elevation
ACTIVE COMPARATORInterventions
Immediate implant surgery applied with the Socket Shield Technique
Eligibility Criteria
You may qualify if:
- Being systemically healthy (ASA classification I-II)
- Being over 18 years old
- Not smoking
- Having good oral hygiene
- Upper incisors and premolars that cannot be restored and have extraction indications
- Periodontally healthy, non-mobile teeth
- The amount and quality of bone suitable for immediate implant placement
You may not qualify if:
- Periodontally unhealthy teeth
- Teeth with vertical root fracture on the buccal surface
- Teeth with a horizontal fracture below the bone level
- Teeth with external and internal resorption affecting the buccal part of the root
- Patients who are pregnant or suspected of pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kutahya Health Sciences University
Kütahya, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Ezgi Gürbüz
Kutahya Health Sciences University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof.
Study Record Dates
First Submitted
August 3, 2022
First Posted
August 9, 2022
Study Start
July 18, 2019
Primary Completion
December 21, 2023
Study Completion
December 7, 2024
Last Updated
December 30, 2024
Record last verified: 2023-10