Socket Shield Technique With or Without Flap Elevation

Not Applicable

Completed

• Conditions: Alveolar Bone Resorption
• Interventions: Procedure: Immediate implantation with the Socket Shield Technique

• Registration Number: NCT05492838
• Lead Sponsor: Kutahya Health Sciences University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-07-18
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-09
• Status Verified: 2023-10
• Primary Completion: 2023-12-21
• Study Completion: 2024-12-07
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flapless Surgery	Immediate implantation with the Socket Shield Technique	-
Surgery With Flap Elevation	Immediate implantation with the Socket Shield Technique	-

Primary Outcome Measures

Name	Time	Method
Change from baseline marginal bone loss at 12 months	Baseline, 12th month	Measurement of marginal bone loss change between baseline and 12th month by cone beam computed tomography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kutahya Health Sciences University; 🇹🇷 Kütahya, Turkey