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Socket Shield Technique With or Without Flap Elevation

NCT ID: NCT05492838

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-18

Study Completion Date

2024-12-07

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.

Conditions

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Alveolar Bone Resorption

Keywords

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Socket Shield Technique Alveolar Bone Preservation Immediate Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flapless Surgery

Group Type ACTIVE_COMPARATOR

Immediate implantation with the Socket Shield Technique

Intervention Type PROCEDURE

Immediate implant surgery applied with the Socket Shield Technique

Surgery With Flap Elevation

Group Type ACTIVE_COMPARATOR

Immediate implantation with the Socket Shield Technique

Intervention Type PROCEDURE

Immediate implant surgery applied with the Socket Shield Technique

Interventions

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Immediate implantation with the Socket Shield Technique

Immediate implant surgery applied with the Socket Shield Technique

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Ezgi Gürbüz

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ezgi Gürbüz

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Sciences University

Locations

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Kutahya Health Sciences University

Kütahya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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02

Identifier Type: -

Identifier Source: org_study_id