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

NCT07613320 | Active Not Recruiting DMC

• 1 other identifier: MS.26.01.119
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate bone and soft tissue changes clinically and digitally after using customized healing Abutment with or without silicate-added beta-tricalcium phosphate (Si-β-TCP) putty

Conditions

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

Keywords

Immediate implant placement; Fully-guided surgery; Esthetic zone; Customized healing abutment; Si-β-TCP putty

Outcome Measures

Primary Outcomes (2)

• Implant stability

  Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).

  Immediate post-operative, 3 months, and 6 months.

• Hard Tissue (Peri-implant bone)

  Marginal bone loss will be assessed using CBCT measured in mm.

  - Preoperative (baseline) - Immediately after implant placement - 6 months after implant placement

Secondary Outcomes (1)

• Soft Tissue

  Baseline, 1 month, 3 months, and 6 months.

Study Arms (2)

Control group

EXPERIMENTAL

Immediate implant placement with customized healing abutment without Si-β-TCP putty in the esthetic zone

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.

Procedure: Silicate-added β-TCP putty for jumping gap grafting

Interventions

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 acustomized healing abutment to enhance peri-implant soft tissue healing and ridge preservation.

Study group (Si-β-TCP Putty Group)

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.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: December 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)