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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05492838
Other study ID # 02
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date July 18, 2019
Est. completion date December 2024

Study information

Verified date October 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 30
Est. completion date December 2024
Est. primary completion date December 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 62 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Immediate implantation with the Socket Shield Technique
Immediate implant surgery applied with the Socket Shield Technique

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Oral health impact profile questionnaire A questionnaire consisting of 14 items Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
Secondary 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
Secondary 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
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