Socket Shield Technique With or Without Flap Elevation

Study Overview
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Brief Summary
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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.

Detailed Description
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Temporary prostheses will be applied to patients in the flap and flapless surgery group 1 week after the surgical procedure, and permanent prostheses will be placed 3 months later. From this date, clinical controls will be made in the 1st, 3rd, 6th months and 1st year. During these controls, biological complications (peri-implant mucositis, peri-implantitis), implant failure and survival rates, and complications related to the socket shield (socket shield exposure, infection) will be evaluated. Marginal bone loss around the implants and bone resorption in the horizontal and vertical directions will be compared between the two groups with cone beam computed tomography taken at the 1st year follow-up. The Oral Health-Related Quality of Life Scale will be applied in the session where the temporary prosthesis is applied 1 week after the surgery, in the 1st month clinical control and in the 3rd and 6th month clinical control after the permanent prosthesis application, in order to evaluate the quality of life related to the surgical and prosthetic application of the patients in both groups, and comparisons between groups will be made. In addition, intraoral photographs will be taken from the patients for aesthetic evaluation before the surgical procedure, at the 1st, 3rd and 6th month clinical control sessions. Pink Aesthetic Score (PES) and White Aesthetic Score (BES) will be evaluated on the photographs, and a comparison will be made between groups in terms of scores.

Official Title
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Clinical and Radiographic Evaluation of Socket Shield Technique With or Without Flap Elevation

Conditions
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Alveolar Bone Resorption

Intervention / Treatment
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* Procedure: Immediate implantation with the Socket Shield Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flapless Surgery<br> | Procedure: Immediate implantation with the Socket Shield Technique<br>* Immediate implant surgery applied with the Socket Shield Technique<br>|
| Active Comparator: Surgery With Flap Elevation<br> | Procedure: Immediate implantation with the Socket Shield Technique<br>* Immediate implant surgery applied with the Socket Shield Technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of peri-implant pocket depth between baseline and follow-up periods | Clinical measurement of change in peri-implant pocket depth between follow-up periods using probe | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| Change of modified plaque index between baseline and follow-up periods | Clinical measurement of change in modified plaque index between follow-up periods using probe | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| Change of modified bleeding index between baseline and follow-up periods | Clinical measurement of change in modified bleeding index between follow-up periods using probe | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| Change in the width of keratinized mucosa between follow-up periods | Clinical measurement of change in the keratinized mucosa width between follow-up periods using probe | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| Change in the mucosal recession between follow-up periods | Clinical measurement of change in the mucosal recession between follow-up periods using probe | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| Change in the mucosal thickness between follow-up periods | Clinical measurement of change in the mucosal thickness between follow-up periods using spreader | Baseline, 1st month, 3rd month, 6th month, 12th month | 
| Visual analog scale | On a scale of 0-10, with 0 indicating the worst and 10 indicating the best choice | Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month | 
| Oral health impact profile questionnaire | A questionnaire consisting of 14 items | Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month | 
| Pink aesthetic score | An index with a minimum score of 0 and a maximum score of 14 | Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month | 
| White aesthetic score | An index with a minimum score of 0 and a maximum score of 10 | Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Socket Shield Technique, Alveolar Bone Preservation, Immediate Implantation