Tooth Loss in the Anterior MaxillaNCT07468760
Peri-Implant Hard and Soft Tissue Changes After Immediate Implant Placement With Socket Shield and Immediate Restoration Versus Early Implant Placement in the Esthetic Zone
A study testing Socket Shield and Early Implant Placement in people with Tooth Loss in the Anterior Maxilla and Alveolar Bone Resorption, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
This randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss in the Anterior Maxilla, Alveolar Bone Resorption, Partial Edentulism of the Maxilla
- What is being tested?
- Socket Shield and Early Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 30 Mar 2026to 1 Sep 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement
- Presence of a thin buccal bone plate (<1 mm)
- Adequate bone volume to allow implant placement in a prosthetically ideal position
- Intact socket walls following tooth extraction
- Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement
- Patients willing to participate in the study and able to provide written informed consent
Who cannot join
- History of systemic diseases that may affect bone healing
- Use of medications that may influence bone metabolism (e.g., bisphosphonates)
- Smoking within the past 5 years
- Presence of acute infection at the surgical site or adjacent teeth
- Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
- Presence of internal or external root resorption
- Severe periodontal destruction at the implant site
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate, 4184
About this study
Official title: Evaluation of Peri-implant Hard And Soft Tissues Changes Between Immediate Implant Placement With Socket Shield Technique and Immediate Restoration Versus Early Type II Implant Placement in The Esthetic Zone - A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. The primary outcome is the Pink Esthetic Score (PES), while secondary outcomes include mid-facial mucosal recession, radiographic vertical and horizontal buccal bone remodeling, and patient satisfaction after 12 months.
Read the detailed description
Immediate implant placement is widely used for replacing non-restorable teeth in the esthetic zone. However, post-extraction remodeling of the buccal bone plate can lead to soft tissue recession and compromised esthetic outcomes. The socket shield technique has been proposed as a partial extraction therapy designed to preserve the buccal root fragment and maintain the facial bone and gingival architecture.
This single-center, prospective randomized controlled clinical trial aims to evaluate the effectiveness of the socket shield technique with immediate implant placement and immediate restoration compared with early type II implant placement with contour augmentation.
Forty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups:
Test group: Immediate implant placement with socket shield technique and immediate restoration.
Control group: Early implant placement following soft tissue healing with contour augmentation.
Clinical, radiographic, and patient-reported outcomes will be assessed over a 12-month follow-up period.
- Conditions
- Tooth Loss in the Anterior Maxilla, Alveolar Bone Resorption, Partial Edentulism of the Maxilla
- Being tested
- Socket Shield, Early Implant Placement
- Keywords
- Socket Shield Technique, Immediate Implant Placement, Early Implant Placement, Pink Esthetic Score, Partial Extraction Therapy, Buccal Bone Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket ShieldProcedure or surgery
Also called Partial Extraction Therapy
mmediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months
Early Implant PlacementProcedure or surgery
Also called Type II Implant Placement
atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech | Experimental | Participants allocated to this experimental group will undergo immediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes. Receives: Procedure: Socket Shield |
| Early Type II Implant placement with Contour augmentation with Xenograft | Active comparator | Participants assigned to this active comparator group will undergo atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration. Participants will be followed for 12 months to assess peri-implant hard and soft tissue changes and esthetic outcomes. Receives: Procedure: Early Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink Esthetic Score (PES)
Evaluation of peri-implant soft tissue esthetic outcome using the Pink Esthetic Score, which assesses seven parameters including mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and texture around the implant restoration. Each parameter is scored from 0 to 2, with a maximum score of 14 indicating optimal esthetic outcome.
Measured: 12 months after implant restoration
Secondary outcomes (4)
Peri-implant Mid-facial Mucosal Recession
Measurement of vertical changes in the mid-facial peri-implant mucosal level. Digital intraoral scans obtained at baseline and during follow-up will be superimposed using digital analysis software to quantify the vertical displacement of the facial mucosal zenith relative to the baseline position.
Measured: 12 months after implant placement
Horizontal Radiographic Peri-implant Bone Changes
Assessment of horizontal dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The horizontal distance between the implant surface and the outer surface of the buccal bone plate will be measured at the mid-buccal aspect 1 mm apical to the buccal bone crest. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine peri-implant bone remodeling.
Measured: 12 months after implant Restoration
Vertical Radiographic Peri-implant Bone Changes
Assessment of vertical dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The vertical distance between the implant platform and the buccal alveolar crest at the mid-buccal aspect of the implant will be measured. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine vertical peri-implant bone remodeling.
Measured: 12 months after implant Restoration
Patient Satisfaction
Patient-reported satisfaction with the implant treatment will be assessed using a Visual Analog Scale (VAS) questionnaire evaluating esthetics and functional outcomes of the implant-supported restoration. The VAS ranges from 0 to 10, where higher scores indicate greater patient satisfaction.
Measured: 12 months after implant restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start30 Mar 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Loss in the Anterior MaxillaStudies 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
- This study is a single-center, prospective, randomized parallel two-arm clinical trial. A total of 42 patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly assigned in a 1:1 ratio to either the test group or the control group using a computer-generated randomization list. The test group will receive immediate implant placement with the socket shield technique and immediate restoration, while the control group will receive early type II implant placement following a healing period of 4-8 weeks with contour augmentation. Outcome assessors and the statistician will be blinded to the treatment allocation. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Atef Sayed, Ph.D., Study chair, Assistant Professor of PeriodonticsMoheb Silwadi, M.D.S, Principal investigator, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468760
- Sponsor's protocol ID
- IRB-COD-STD-87-Feb-2025
- Other IDs
- IRB-COD-STD-87-Feb-2025
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-implant Hard And Soft Tissues Changes Between Immediate Implant Placement With Socket Shield Technique and Immediate Restoration Versus Early Type II Implant Placement in The Esthetic Zone - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07468760
- Acronym / sponsor ID
- IRB-COD-STD-87-Feb-2025
- Conditions
- Tooth Loss in the Anterior Maxilla, Alveolar Bone Resorption, Partial Edentulism of the Maxilla
- Keywords
- Socket Shield Technique, Immediate Implant Placement, Early Implant Placement, Pink Esthetic Score, Partial Extraction Therapy, Buccal Bone Remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 13 Mar 2026 (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 randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. The primary outcome is the Pink Esthetic Score (PES), while secondary outcomes include mid-facial mucosal recession, radiographic vertical and horizontal buccal bone remodeling, and patient satisfaction after 12 months.
Detailed description
Immediate implant placement is widely used for replacing non-restorable teeth in the esthetic zone. However, post-extraction remodeling of the buccal bone plate can lead to soft tissue recession and compromised esthetic outcomes. The socket shield technique has been proposed as a partial extraction therapy designed to preserve the buccal root fragment and maintain the facial bone and gingival architecture.
This single-center, prospective randomized controlled clinical trial aims to evaluate the effectiveness of the socket shield technique with immediate implant placement and immediate restoration compared with early type II implant placement with contour augmentation.
Forty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups:
Test group: Immediate implant placement with socket shield technique and immediate restoration.
Control group: Early implant placement following soft tissue healing with contour augmentation.
Clinical, radiographic, and patient-reported outcomes will be assessed over a 12-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-center, prospective, randomized parallel two-arm clinical trial. A total of 42 patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly assigned in a 1:1 ratio to either the test group or the control group using a computer-generated randomization list. The test group will receive immediate implant placement with the socket shield technique and immediate restoration, while the control group will receive early type II implant placement following a healing period of 4-8 weeks with contour augmentation. Outcome assessors and the statistician will be blinded to the treatment allocation. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes.
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech | Experimental | Procedure: Socket ShieldParticipants allocated to this experimental group will undergo immediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes. |
| Early Type II Implant placement with Contour augmentation with Xenograft | Active comparator | Procedure: Early Implant PlacementParticipants assigned to this active comparator group will undergo atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration. Participants will be followed for 12 months to assess peri-implant hard and soft tissue changes and esthetic outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older
- Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement
- Presence of a thin buccal bone plate (<1 mm)
- Adequate bone volume to allow implant placement in a prosthetically ideal position
- Intact socket walls following tooth extraction
Key exclusion criteria (7 listed)
- History of systemic diseases that may affect bone healing
- Use of medications that may influence bone metabolism (e.g., bisphosphonates)
- Smoking within the past 5 years
- Presence of acute infection at the surgical site or adjacent teeth
- Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
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 |
|---|---|---|
| Socket ShieldAlso: Partial Extraction Therapymmediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months | Procedure or surgery | Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech |
| Early Implant PlacementAlso: Type II Implant Placementatraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration | Procedure or surgery | Early Type II Implant placement with Contour augmentation with Xenograft |
Primary outcome
Pink Esthetic Score (PES)
Time frame: 12 months after implant restoration
Evaluation of peri-implant soft tissue esthetic outcome using the Pink Esthetic Score, which assesses seven parameters including mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and texture around the implant restoration. Each parameter is scored from 0 to 2, with a maximum score of 14 indicating optimal esthetic outcome.
4 secondary outcomes
Peri-implant Mid-facial Mucosal Recession
Time frame: 12 months after implant placement
Horizontal Radiographic Peri-implant Bone Changes
Time frame: 12 months after implant Restoration
Vertical Radiographic Peri-implant Bone Changes
Time frame: 12 months after implant Restoration
Patient Satisfaction
Time frame: 12 months after implant restoration
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Mohamed Atef Sayed, Ph.D. study chair
Assistant Professor of Periodontics
Moheb Silwadi, M.D.S principal investigator
Gulf Medical 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 Socket Shield and Early Implant Placement in people with Tooth Loss in the Anterior Maxilla and Alveolar Bone Resorption, run by Gulf Medical University at 1 site in United Arab Emirates.
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 7 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 3 Nov 2026. 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 United Arab Emirates. 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?
Pink Esthetic Score (PES) (time frame: 12 months after implant restoration). 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 3 Nov 2026.