Clinical trial NCT05492838: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Resorption
Keywords: Socket Shield Technique
Alveolar Bone Preservation
Immediate Implantation
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline marginal bone loss at 12 months
timeFrame: Baseline, 12th month
Secondary outcomes:
measure: Change of peri-implant pocket depth between baseline and follow-up periods
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: Change of modified plaque index between baseline and follow-up periods
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: Change of modified bleeding index between baseline and follow-up periods
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: Change in the width of keratinized mucosa between follow-up periods
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: Change in the mucosal recession between follow-up periods
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: Change in the mucosal thickness between follow-up periods
timeFrame: Baseline, 1st month, 3rd month, 6th month, 12th month
measure: Visual analog scale
timeFrame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
measure: Oral health impact profile questionnaire
timeFrame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
measure: Pink aesthetic score
timeFrame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
measure: White aesthetic score
timeFrame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Ezgi Gürbüz
role: PRINCIPAL_INVESTIGATOR
References: