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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07613320
Acronym
SA-TCP Implant
Enrollment
72
Registered
2026-05-29
Start date
2025-12-01
Completion date
2026-07-30
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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.

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.

Interventions

PROCEDURESilicate-added β-TCP putty for jumping gap grafting

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.

PROCEDUREConventional healing/ No graft

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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with non-restorable teeth in maxillary esthetic zone requiring dental extraction. 2. Adequate inter-arch relation and inter-occlusal space to accommodate the prosthetic restoration. 3. Jumping gap more than 2mm. 4. Patients with good oral hygiene. 5. Patients willing to participate in the study's follow-up intervals.

Exclusion criteria

1. Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement. 2. Alcohol or drug abuse. 3. Smokers. 4. Patients with systemic diseases that absolutely contraindicate implant placement (bleeding disorders, immunosuppression,…etc.) 5. Pregnancy. 6. Patients with para-functional habits (bruxism and clenching). 7. Lack of motivation or inability to maintain good oral hygiene. \-

Design outcomes

Primary

MeasureTime frameDescription
Implant stabilityImmediate post-operative, 3 months, and 6 months.Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
Hard Tissue (Peri-implant bone)- Immediately after implant placement - 6 months after implant placementMarginal bone loss will be assessed using CBCT measured in mm.

Secondary

MeasureTime frameDescription
Soft TissueBaseline, 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026