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Completed

NCT Number: NCT05492838

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.

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Key information

Conditions

Alveolar Bone Resorption

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate implantation with the Socket Shield Technique

Procedure

Immediate implant surgery applied with the Socket Shield Technique

Primary outcomes

  1. Change from baseline marginal bone loss at 12 months

    Time frame: Baseline, 12th month

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

Secondary outcomes

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

    Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month

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

  2. Change of modified plaque index between baseline and follow-up periods

    Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month

    Clinical measurement of change in modified plaque index between follow-up periods using probe

  3. Change of modified bleeding index between baseline and follow-up periods

    Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month

    Clinical measurement of change in modified bleeding index between follow-up periods using probe

  4. Change in the width of keratinized mucosa between follow-up periods

    Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month

    Clinical measurement of change in the keratinized mucosa width between follow-up periods using probe

  5. Change in the mucosal recession between follow-up periods

    Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month

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

  6. Change in the mucosal thickness between follow-up periods

    Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month

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

  7. Visual analog scale

    Time frame: 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

  8. Oral health impact profile questionnaire

    Time frame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month

    A questionnaire consisting of 14 items

  9. Pink aesthetic score

    Time frame: 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

  10. White aesthetic score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Aug 9, 2022
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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