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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
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

Other trials in Egypt

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.

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 groups in NCT07613320
Study groupRoleWhat they receive
Control groupExperimentalImmediate 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)ExperimentalImmediate 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.

  1. 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.

  2. 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)
  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.

  1. First posted29 May 2026
  2. Study start1 Dec 2025
  3. Primary completion30 Jun 2026
  4. Study completion30 Jul 2026

Resources

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)
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

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