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Socket Shield Technique With or Without Flap Elevation

Primary Purpose

Alveolar Bone Resorption

Status

Suspended

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Immediate implantation with the Socket Shield Technique

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption focused on measuring Socket Shield Technique, Alveolar Bone Preservation, Immediate Implantation

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Kutahya Health Sciences University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Flapless Surgery

Surgery With Flap Elevation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Change in the mucosal recession between follow-up periods

Clinical measurement of change in the mucosal recession between follow-up periods using probe

Change in the mucosal thickness between follow-up periods

Clinical measurement of change in the mucosal thickness between follow-up periods using spreader

Visual analog scale

On a scale of 0-10, with 0 indicating the worst and 10 indicating the best choice

Oral health impact profile questionnaire

A questionnaire consisting of 14 items

Pink aesthetic score

An index with a minimum score of 0 and a maximum score of 14

White aesthetic score

An index with a minimum score of 0 and a maximum score of 10

Full Information

NCT ID

NCT05492838

First Posted

August 3, 2022

Last Updated

October 2, 2023

Sponsor

Kutahya Health Sciences University

1. Study Identification

Unique Protocol Identification Number

NCT05492838

Brief Title

Socket Shield Technique With or Without Flap Elevation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Suspended

Why Stopped

Due to the small sample size in flap elevation group

Study Start Date

July 18, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Bone Resorption

Keywords

Socket Shield Technique, Alveolar Bone Preservation, Immediate Implantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Flapless Surgery

Arm Type

Active Comparator

Arm Title

Surgery With Flap Elevation

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Immediate implantation with the Socket Shield Technique

Intervention Description

Immediate implant surgery applied with the Socket Shield Technique

Primary Outcome Measure Information:

Title

Change from baseline marginal bone loss at 12 months

Description

Measurement of marginal bone loss change between baseline and 12th month by cone beam computed tomography

Time Frame

Baseline, 12th month

Secondary Outcome Measure Information:

Title

Change of peri-implant pocket depth between baseline and follow-up periods

Description

Clinical measurement of change in peri-implant pocket depth between follow-up periods using probe

Time Frame