Tooth Loss in the Esthetic Zone Requiring Immediate Implant PlacementSA-TCP ImplantNCT07613320
Silicate-Added Beta-TCP in Fully Guided Immediate Implants in the Esthetic Zone
A study testing Silicate-added β-TCP putty for jumping gap grafting and Conventional healing/ No graft in people with Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement and Bone Grafting, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement, Bone Grafting, Customized Healing Abutment
- What is being tested?
- Silicate-added β-TCP putty for jumping gap grafting and Conventional healing/ No graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 30 Jul 2026
- Phase
- Interventional
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement, Bone Grafting, Customized Healing Abutment, Immediate Dental Implant Placement
- Being tested
- Silicate-added β-TCP putty for jumping gap grafting, Conventional healing/ No graft
- Keywords
- Immediate implant placement, Fully-guided surgery, Esthetic zone, Customized healing abutment, Si-β-TCP putty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicate-added β-TCP putty for jumping gap graftingProcedure or surgery
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.
Conventional healing/ No graftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Immediate implant placement with customized healing abutment without Si-β-TCP putty in the esthetic zone. Receives: Procedure: Conventional healing/ No graft |
| Study group (Si-β-TCP Putty Group) | Experimental | Immediate implant placement with silicate-added beta-tricalcium phosphate putty and customized healing abutment in the esthetic zone. Receives: Procedure: Silicate-added β-TCP putty for jumping gap grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
Measured: Immediate post-operative, 3 months, and 6 months.
Hard Tissue (Peri-implant bone)
Marginal bone loss will be assessed using CBCT measured in mm.
Measured: - Immediately after implant placement - 6 months after implant placement
Secondary outcomes (1)
Soft Tissue
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).
Measured: Baseline, 1 month, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Dec 2025
- Primary completion30 Jun 2026
- Study completion30 Jul 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 Esthetic Zone Requiring Immediate Implant PlacementStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613320
- Sponsor's protocol ID
- MS.26.01.119
- Acronym
- SA-TCP Implant
- Status last verified
- Sep 2026
- First submitted
- 22 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No