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NCT Number: NCT07613320

Silicate-Added Beta-TCP in Fully Guided Immediate Implants in the Esthetic Zone

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement Bone Grafting Customized Healing Abutment Immediate Dental Implant Placement

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Silicate-added β-TCP putty for jumping gap grafting

Procedure

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 graft

Procedure

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Evaluation of Silicate-Added Beta-Tricalcium Phosphate Putty in Fully-Guided Immediate Implants in the Esthetic Zone Using Customized Healing Abutment

Acronym: SA-TCP Implant

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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