Alveolar Bone ResorptionNCT05492838
Socket Shield Technique With or Without Flap Elevation
A study testing Immediate implantation with the Socket Shield Technique in people with Alveolar Bone Resorption, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Immediate implantation with the Socket Shield Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jul 2019to 7 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of 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.
Read the 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.
- Conditions
- Alveolar Bone Resorption
- Being tested
- Immediate implantation with the Socket Shield Technique
- Keywords
- Socket Shield Technique, Alveolar Bone Preservation, Immediate Implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implantation with the Socket Shield TechniqueProcedure or surgery
Immediate implant surgery applied with the Socket Shield Technique
| Study group | Role | What they receive |
|---|---|---|
| Flapless Surgery | Active comparator | Not described Receives: Procedure: Immediate implantation with the Socket Shield Technique |
| Surgery With Flap Elevation | Active comparator | Not described Receives: Procedure: Immediate implantation with the Socket Shield Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12th month
Secondary outcomes (10)
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
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
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
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
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
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
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
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
Change in the mucosal recession between follow-up periods
Clinical measurement of change in the mucosal recession between follow-up periods using probe
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
Change in the mucosal thickness between follow-up periods
Clinical measurement of change in the mucosal thickness between follow-up periods using spreader
Measured: Baseline, 1st month, 3rd month, 6th month, 12th month
Visual analog scale
On a scale of 0-10, with 0 indicating the worst and 10 indicating the best choice
Measured: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
Oral health impact profile questionnaire
A questionnaire consisting of 14 items
Measured: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
Pink aesthetic score
An index with a minimum score of 0 and a maximum score of 14
Measured: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
White aesthetic score
An index with a minimum score of 0 and a maximum score of 10
Measured: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start18 Jul 2019
- Primary completion21 Dec 2023
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Gürbüz, Kutahya Health Sciences University
- Investigators
- Ezgi Gürbüz, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492838
- Sponsor's protocol ID
- 02
- Status last verified
- Oct 2023
- First submitted
- 3 Aug 2022
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Socket Shield Technique With or Without Flap Elevation
- ClinicalTrials.gov ID
- NCT05492838
- Acronym / sponsor ID
- 02
- Conditions
- Alveolar Bone Resorption
- Keywords
- Socket Shield Technique, Alveolar Bone Preservation, Immediate Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flapless Surgery | Active comparator | Procedure: Immediate implantation with the Socket Shield Technique |
| Surgery With Flap Elevation | Active comparator | Procedure: Immediate implantation with the Socket Shield Technique |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate implantation with the Socket Shield TechniqueImmediate implant surgery applied with the Socket Shield Technique | Procedure or surgery | Flapless Surgery, Surgery With Flap Elevation |
Primary outcome
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
10 secondary outcomes
Change of peri-implant pocket depth between baseline and follow-up periods
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
Change of modified plaque index between baseline and follow-up periods
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
Change of modified bleeding index between baseline and follow-up periods
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
Change in the width of keratinized mucosa between follow-up periods
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
Change in the mucosal recession between follow-up periods
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
Change in the mucosal thickness between follow-up periods
Time frame: Baseline, 1st month, 3rd month, 6th month, 12th month
Visual analog scale
Time frame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
Oral health impact profile questionnaire
Time frame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
Pink aesthetic score
Time frame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
White aesthetic score
Time frame: Baseline, 1st week, 1st month, 3rd month, 6th month, 12th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezgi Gürbüz principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implantation with the Socket Shield Technique in people with Alveolar Bone Resorption, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline marginal bone loss at 12 months (time frame: Baseline, 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.