- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460648
Two Stage Modified Socket Shield: Grafted vs Nongrafted (SST)
March 9, 2026 updated by: Mai Ahmed Haggag, Mansoura University
"Spontaneous Bone Healing in Two Stage Modified Socket Shield Therapy" Can It Be a Dependable Approach for Delayed Implant Placement? A Randomized Controlled Trial
Modified socket shield therapy (SST) has been proposed to preserve the facial plate and peri implant tissues.
Whether spontaneous healing after two stage modified SST provides outcomes comparable to grafted SST before delayed implant placement remains unclear.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There remains no consensus regarding management of the space adjacent to the retained shield-whether it should be filled with a biomaterial or left for spontaneous healing.
Clinical observations suggest that healing may not always yield complete mineralized fill; instead, a soft tissue interface can develop along the internal aspect of the root fragment, potentially limiting bone formation within the defect.
At present, it remains unclear whether placement of a bone substitute can reliably reduce or prevent this soft tissue ingrowth along the inner surface of the retained fragment, providing a rationale for controlled comparisons of grafted and nongrafted two stage SST protocols.
Therefore, the present controlled clinical study was designed to compare SST with xenograft combined with MPM augmentation versus SST alone, followed by delayed implant placement after a 6 month healing period.
The study evaluated soft tissue ingrowth as key healing outcomes, alongside histologic findings and implant related parameters, including implant stability, as well as the incidence and management of procedure related complications.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Al Mansurah, Egypt
- Faculty of Dentistry - Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ASA I (healthy)
- With intact buccal periodontal tissues
- No parafunctional habits
- Good oral hygiene
- Willingness to comply with the study protocol and follow up schedule
Exclusion Criteria:
- Acute infection at the extraction site
- Extensive buccal plate loss
- Vertical root fracture on the buccal aspect
- Fracture patterns extending below bone level
- Internal or external resorption
- Root caries compromising the shield
- Excessive tooth mobility
- Heavy smoking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
Socket Shield Technique alone with spontaneous healing
|
No grafting material was placed, and the socket was closed with a figure-of-eight suture to stabilize the clot
The xenograft/MPM mixture was gently packed into the shield-associated space/socket without excessive compression, and the socket was sealed and stabilized using a figure-of-eight suture technique
|
|
Experimental: Test Group
Socket Shield Technique with MPM augmentation
|
No grafting material was placed, and the socket was closed with a figure-of-eight suture to stabilize the clot
The xenograft/MPM mixture was gently packed into the shield-associated space/socket without excessive compression, and the socket was sealed and stabilized using a figure-of-eight suture technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Soft tissue ingrowth dimension: depth
Time Frame: 6-month (at the time of implant placement)
|
Soft tissue ingrowth dimensions; depth and width were measured using a calibrated periodontal probe with readings taken to the nearest millimeter and rounded up when the probe reading reached or exceeded the midpoint between millimeter markings.
Depth (mm) was recorded from the most coronal aspect of the retained root fragment and measured apically until hard tissue was encountered.
|
6-month (at the time of implant placement)
|
|
Soft tissue ingrowth dimension: width
Time Frame: 6-month (at the time of implant placement)
|
Width (mm) was measured in a buccopalatal direction from the central aspect of the socket shield to the point where hard tissue was reached, representing the maximum diameter of the soft tissue ingrowth.
|
6-month (at the time of implant placement)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
January 31, 2026
Study Registration Dates
First Submitted
February 28, 2026
First Submitted That Met QC Criteria
March 9, 2026
First Posted (Actual)
March 10, 2026
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 9, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.26.02.109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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