Silicate-Added Beta-TCP in Fully Guided Immediate Implants in the Esthetic Zone (SA-TCP Implant)
July 8, 2026 updated by: Mansoura University
Evaluation of Silicate-Added Beta-Tricalcium Phosphate Putty in Fully-Guided Immediate Implants in the Esthetic Zone Using Customized Healing Abutment
This study aims to evaluate bone and soft tissue changes clinically and digitally after using a customized healing Abutment with or without silicate-added beta-tricalcium phosphate (Si-β-TCP) putty.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Fully guided immediate implant placement in the esthetic zone presents challenges related to soft tissue closure, jumping gap management, and peri-implant stability.
The use of silicate-added β-TCP putty with customized healing abutments has been proposed to improve soft tissue healing and maintain peri-implant architecture.
Study Type
Interventional
Enrollment (Actual)
72
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
-
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypt
- Faculty of Dentistry Mansoura University
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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:
- Patients with non-restorable teeth in maxillary esthetic zone requiring dental extraction.
- Adequate inter-arch relation and inter-occlusal space to accommodate the prosthetic restoration.
- Jumping gap more than 2mm.
- Patients with good oral hygiene.
- Patients willing to participate in the study's follow-up intervals.
Exclusion Criteria:
- Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
- Alcohol or drug abuse.
- Smokers.
- Patients with systemic diseases that absolutely contraindicate implant placement (bleeding disorders, immunosuppression,…etc.)
- Pregnancy.
- Patients with para-functional habits (bruxism and clenching).
Lack of motivation or inability to maintain good oral hygiene.
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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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group (Si-β-TCP Putty Group)
Immediate implant placement with silicate-added beta-tricalcium phosphate putty and customized healing abutment in the esthetic zone.
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Application of silicate-added beta-tricalcium phosphate putty in the jumping gap around fully-guided immediate implants placed in the esthetic zone, combined with provisional crown as a customized healing abutment to enhance peri-implant soft tissue healing and ridge preservation.
|
|
Experimental: Control group
Immediate implant placement with customized healing abutment without Si-β-TCP putty in the esthetic zone.
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Standard fully-guided implant placement protocol without the use of bone graft material allowing natural healing of the jumping gap around immediately placed implants in the esthetic zone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant stability
Time Frame: Immediate post-operative, 3 months, and 6 months.
|
Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
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Immediate post-operative, 3 months, and 6 months.
|
|
Hard Tissue (Peri-implant bone)
Time Frame: - Immediately after implant placement - 6 months after implant placement
|
Marginal bone loss will be assessed using CBCT measured in mm.
|
- Immediately after implant placement - 6 months after implant placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Soft Tissue
Time Frame: Baseline, 1 month, 3 months, and 6 months.
|
Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition and modified sulcus bleeding index (mSBI).
|
Baseline, 1 month, 3 months, and 6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2025
Primary Completion (Actual)
June 30, 2026
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
May 22, 2026
First Submitted That Met QC Criteria
May 22, 2026
First Posted (Actual)
May 29, 2026
Study Record Updates
Last Update Posted (Actual)
July 10, 2026
Last Update Submitted That Met QC Criteria
July 8, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MS.26.01.119
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.