Socket Shield Technique With or Without Flap Elevation

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

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.

Study Overview

• Status: Suspended
• Conditions: Alveolar Bone Resorption
• Intervention / Treatment: Procedure: Immediate implantation with the Socket Shield Technique

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kütahya, Turkey
    • Kütahya Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flapless Surgery	Procedure: Immediate implantation with the Socket Shield Technique; Immediate implant surgery applied with the Socket Shield Technique
Active Comparator: Surgery With Flap Elevation	Procedure: Immediate implantation with the Socket Shield Technique; Immediate implant surgery applied with the Socket Shield Technique

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Ezgi Gürbüz, Kütahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Actual): December 21, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Socket Shield Technique; Alveolar Bone Preservation; Immediate Implantation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: 02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No