Alveolar Ridge PreservationSSTNCT07171866
Socket Shield Technique for Immediate and Delayed Implant Placement: A 6-Year Clinical Tria
A study testing Immediate Implant Placement with SST and Delayed Implant Placement with SST in people with Alveolar Ridge Preservation and Implant Dentistry, run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.
Trial summary
This study investigates the long-term performance of the Socket Shield Technique (SST) for preserving the bone and soft tissue around dental implants when used with two different timing protocols: immediate versus delayed implant placement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alveolar Ridge Preservation, Implant Dentistry
- What is being tested?
- Immediate Implant Placement with SST and Delayed Implant Placement with SST
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Jul 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring single-tooth replacement in the anterior maxilla (esthetic zone)
- Age between 18-65 years
- Good systemic health
- Demonstrated good oral hygiene
- Presence of an intact buccal plate
- Class I or II sagittal root position
Show all 9Show fewer
- Sufficient apical bone volume and quality for implant placement
- Willingness and ability to comply with study protocol and follow-up schedule
- Signed informed consent
Who cannot join
- Presence of acute infection at the extraction site (e.g., abscess)
- Vertical root fracture or advanced periodontitis with buccal plate loss
- Uncontrolled systemic disease (e.g., diabetes, osteoporosis)
- Parafunctional habits (e.g., bruxism, clenching)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: From Esthetics to Function: Can Socket Shield Technique Prove Long-term Effectiveness Either With Immediate or Delayed Implant Placement Protocols? A 6-Year Randomized Clinical Trial
This study investigates the long-term performance of the Socket Shield Technique (SST) for preserving the bone and soft tissue around dental implants when used with two different timing protocols: immediate versus delayed implant placement.
SST is a surgical technique where a thin portion of the tooth root (the buccal shield) is intentionally retained to support the facial bone and gum tissues after tooth extraction. While SST is known to enhance esthetics and preserve bone in the short term, little evidence exists on its long-term effectiveness in different clinical scenarios.
Read more
This randomized clinical trial enrolled patients who needed single-tooth implants in the esthetic zone. Participants were randomly assigned to one of two groups:
Immediate SST group: the implant was placed at the same time the socket shield was prepared.
Delayed SST group: implant placement was performed six months after socket shield preparation.
Over a 6-year follow-up period, both groups were evaluated for:
Changes in ridge width and bone height using CBCT imaging. Esthetic outcomes using the Pink Esthetic Score (PES). Patient satisfaction through a structured questionnaire.
The goal is to determine whether SST offers reliable long-term outcomes in either immediate or delayed implant placement scenarios, supporting its broader clinical use.
Read the detailed description
This randomized controlled clinical trial was conducted to compare the long-term clinical, radiographic, esthetic, and patient-reported outcomes of the SST when used with either immediate or delayed implant placement in the anterior maxilla.
Study Design:
Parallel-arm, randomized controlled trial Conducted at the Faculty of Dentistry, Mansoura University Sample: 25 patients needing single-tooth replacement
Groups:
Immediate SST: implant placed at time of shield preparation Delayed SST: implant placed after 6-month healing
Primary Outcome:
Ridge Width Change: measured at 1 mm, 2 mm, 4 mm, and 6 mm apical to the implant platform using standardized CBCT imaging at baseline, 1 year, and 6 years.
Secondary Outcomes:
Buccal/Palatal Bone Height Implant Stability Pink Esthetic Score Patient Satisfaction
Serial CBCT scans were superimposed using the Fusion module of OnDemand3D software for precise assessment. All clinical assessments were performed by calibrated, blinded examiners. Statistical analysis was performed using SPSS, with significance set at p < 0.05.
This study provides one of the first long-term comparative evaluations of SST in different implant placement protocols, offering evidence to support its clinical reliability over a 6-year period.
- Conditions
- Alveolar Ridge Preservation, Implant Dentistry
- Being tested
- Immediate Implant Placement with SST, Delayed Implant Placement with SST
- Keywords
- Socket Shield Technique, Immediate Implant Placement, Delayed Implant Placement, CBCT, Ridge Width Change, Pink Esthetic Score, Alveolar Ridge Preservation, Long-term Implant Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Implant Placement with SSTProcedure or surgery
Participants underwent extraction and socket shield preparation, followed by immediate implant placement in the esthetic maxillary zone. The implant was inserted at the same surgical session using a flapless or minimally invasive approach. CBCT was used to guide planning and assess ridge dimensions. Healing and follow-up assessments were conducted at 1 year and 6 years post-placement.
Delayed Implant Placement with SSTProcedure or surgery
Participants underwent extraction and socket shield preparation. Implant placement was delayed for 6 months to allow soft and hard tissue healing. The implant was placed after verifying shield stability and ridge preservation via CBCT. Follow-up assessments were conducted at 1 year and 6 years post-placement.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implant Placement with SST | Active comparator | Participants received the SST with immediate implant placement performed at the time of extraction. Receives: Procedure: Immediate Implant Placement with SST |
| Delayed Implant Placement with SST | Active comparator | Participants received the SST with delayed implant placement, performed 6 months after extraction and shield preparation. Receives: Procedure: Delayed Implant Placement with SST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Ridge Width Change at 1, 2, 4, and 6 mm Apical to the Implant Platform
Ridge width was measured at 1 mm, 2 mm, 4 mm, and 6 mm apical to the implant platform using standardized CBCT scans. Superimposed scans were aligned using the Fusion module of OnDemand3D™ software. Changes in horizontal ridge width were calculated by subtracting baseline values from those at 1 year and 6 years to assess dimensional stability over time.
Unit of Measure: → Millimeters (mm) Safety Issue: → No
Measured: Immediately after implant placement (baseline), 1 year, and 6 years post-placement
Secondary outcomes (4)
Buccal and Palatal Bone Height Change
Bone height was measured from the implant apex to the most coronal point of the buccal and palatal bone crest using CBCT. Changes were calculated at each follow-up relative to baseline.
Unit of Measure: → Millimeters (mm) Safety Issue: → No
Measured: Immediately after implant placement (baseline), 1 year, and 6 years post-placement
Implant Stability Quotient (ISQ)
Implant stability was assessed using a resonance frequency analysis device (Osstell ISQ). Buccolingual and mesiodistal values were averaged to calculate ISQ.
Unit of Measure:
→ ISQ Units
Safety Issue:
→ No
Measured: Immediately after implant placement, loading time and 1-year post-placement
Pink Esthetic Score (PES)
The esthetic outcome was assessed using the PES, evaluating five parameters each scored from 0-2. Total PES ranges from 0-10, with ≥6 considered clinically acceptable.
Unit of Measure: → Score (0-10) Safety Issue: → No
Measured: At implant loading, 1 year, and 6 years post-placement
Patient Satisfaction (VAS Score)
Satisfaction was measured using a 100 mm visual analog scale (VAS) on three dimensions: overall experience, expectations, and esthetics. Scores were converted into percentages.
Unit of Measure: → VAS (%) Safety Issue: → No
Measured: At implant loading, 1 year, and 6 years post-placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Feb 2019
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies 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
- Model description
- Participants were randomized into two parallel groups: one receiving immediate implant placement and the other delayed placement following the SST. Each group followed the assigned intervention protocol throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soaad Tolba Mohammed Tolba Badawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soaad Tolba Mohammed Tolba Badawi, Mansoura University
- Investigators
- Soaad Tolba Badawy, Lecturer, Oral Surgery, MU, Principal investigator, Faculty of dentistry, Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171866
- Sponsor's protocol ID
- R.25.09.21
- Acronym
- SST
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared due to privacy considerations, and limitations in participant consent regarding external data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Esthetics to Function: Can Socket Shield Technique Prove Long-term Effectiveness Either With Immediate or Delayed Implant Placement Protocols? A 6-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07171866
- Acronym / sponsor ID
- SST / R.25.09.21
- Conditions
- Alveolar Ridge Preservation, Implant Dentistry
- Keywords
- Socket Shield Technique, Immediate Implant Placement, Delayed Implant Placement, CBCT, Ridge Width Change, Pink Esthetic Score, Alveolar Ridge Preservation, Long-term Implant Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Soaad Tolba Mohammed Tolba BadawiUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 15 Sep 2025 (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.
This study investigates the long-term performance of the Socket Shield Technique (SST) for preserving the bone and soft tissue around dental implants when used with two different timing protocols: immediate versus delayed implant placement.
SST is a surgical technique where a thin portion of the tooth root (the buccal shield) is intentionally retained to support the facial bone and gum tissues after tooth extraction. While SST is known to enhance esthetics and preserve bone in the short term, little evidence exists on its long-term effectiveness in different clinical scenarios.
This randomized clinical trial enrolled patients who needed single-tooth implants in the esthetic zone. Participants were randomly assigned to one of two groups:
Immediate SST group: the implant was placed at the same time the socket shield was prepared.
Delayed SST group: implant placement was performed six months after socket shield preparation.
Over a 6-year follow-up period, both groups were evaluated for:
Changes in ridge width and bone height using CBCT imaging. Esthetic outcomes using the Pink Esthetic Score (PES). Patient satisfaction through a structured questionnaire.
The goal is to determine whether SST offers reliable long-term outcomes in either immediate or delayed implant placement scenarios, supporting its broader clinical use.
Detailed description
This randomized controlled clinical trial was conducted to compare the long-term clinical, radiographic, esthetic, and patient-reported outcomes of the SST when used with either immediate or delayed implant placement in the anterior maxilla.
Study Design:
Parallel-arm, randomized controlled trial Conducted at the Faculty of Dentistry, Mansoura University Sample: 25 patients needing single-tooth replacement
Groups:
Immediate SST: implant placed at time of shield preparation Delayed SST: implant placed after 6-month healing
Primary Outcome:
Ridge Width Change: measured at 1 mm, 2 mm, 4 mm, and 6 mm apical to the implant platform using standardized CBCT imaging at baseline, 1 year, and 6 years.
Secondary Outcomes:
Buccal/Palatal Bone Height Implant Stability Pink Esthetic Score Patient Satisfaction
Serial CBCT scans were superimposed using the Fusion module of OnDemand3D software for precise assessment. All clinical assessments were performed by calibrated, blinded examiners. Statistical analysis was performed using SPSS, with significance set at p < 0.05.
This study provides one of the first long-term comparative evaluations of SST in different implant placement protocols, offering evidence to support its clinical reliability over a 6-year period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized into two parallel groups: one receiving immediate implant placement and the other delayed placement following the SST. Each group followed the assigned intervention protocol throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant Placement with SST | Active comparator | Procedure: Immediate Implant Placement with SSTParticipants received the SST with immediate implant placement performed at the time of extraction. |
| Delayed Implant Placement with SST | Active comparator | Procedure: Delayed Implant Placement with SSTParticipants received the SST with delayed implant placement, performed 6 months after extraction and shield preparation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients requiring single-tooth replacement in the anterior maxilla (esthetic zone)
- Age between 18-65 years
- Good systemic health
- Demonstrated good oral hygiene
- Presence of an intact buccal plate
Key exclusion criteria (4 listed)
- Presence of acute infection at the extraction site (e.g., abscess)
- Vertical root fracture or advanced periodontitis with buccal plate loss
- Uncontrolled systemic disease (e.g., diabetes, osteoporosis)
- Parafunctional habits (e.g., bruxism, clenching)
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 Implant Placement with SSTParticipants underwent extraction and socket shield preparation, followed by immediate implant placement in the esthetic maxillary zone. The implant was inserted at the same surgical session using a flapless or minimally invasive approach. CBCT was used to guide planning and assess ridge dimensions. Healing and follow-up assessments were conducted at 1 year and 6 years post-placement. | Procedure or surgery | Immediate Implant Placement with SST |
| Delayed Implant Placement with SSTParticipants underwent extraction and socket shield preparation. Implant placement was delayed for 6 months to allow soft and hard tissue healing. The implant was placed after verifying shield stability and ridge preservation via CBCT. Follow-up assessments were conducted at 1 year and 6 years post-placement. | Procedure or surgery | Delayed Implant Placement with SST |
Primary outcome
Horizontal Ridge Width Change at 1, 2, 4, and 6 mm Apical to the Implant Platform
Time frame: Immediately after implant placement (baseline), 1 year, and 6 years post-placement
Ridge width was measured at 1 mm, 2 mm, 4 mm, and 6 mm apical to the implant platform using standardized CBCT scans. Superimposed scans were aligned using the Fusion module of OnDemand3D™ software. Changes in horizontal ridge width were calculated by subtracting baseline values from those at 1 year and 6 years to assess dimensional stability over time. Unit of Measure: → Millimeters (mm) Safety Issue: → No
4 secondary outcomes
Buccal and Palatal Bone Height Change
Time frame: Immediately after implant placement (baseline), 1 year, and 6 years post-placement
Implant Stability Quotient (ISQ)
Time frame: Immediately after implant placement, loading time and 1-year post-placement
Pink Esthetic Score (PES)
Time frame: At implant loading, 1 year, and 6 years post-placement
Patient Satisfaction (VAS Score)
Time frame: At implant loading, 1 year, and 6 years post-placement
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 17 Sep 2025.
- Individual participant dataSharing planned: No. The individual participant data will not be shared due to privacy considerations, and limitations in participant consent regarding external data sharing.
Related trials for Alveolar Ridge Preservation
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Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
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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.
Soaad Tolba Badawy, Lecturer, Oral Surgery, MU principal investigator
Faculty of dentistry, Mansoura 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 Implant Placement with SST and Delayed Implant Placement with SST in people with Alveolar Ridge Preservation and Implant Dentistry, run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.
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 9 inclusion and 4 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 17 Sep 2025. 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 Egypt. 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?
Horizontal Ridge Width Change at 1, 2, 4, and 6 mm Apical to the Implant Platform (time frame: Immediately after implant placement (baseline), 1 year, and 6 years post-placement). 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 17 Sep 2025.