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

N/AActive Not RecruitingNCT07613320

Mansoura University72 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Silicate-added β-TCP putty for jumping gap graftingPROCEDURE

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.

Conventional healing/ No graftPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. \-

Locations (1)

Faculty of Dentistry Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Implant stability

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

Time frame: Immediate post-operative, 3 months, and 6 months.

Hard Tissue (Peri-implant bone)

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

Time frame: - Preoperative (baseline) - Immediately after implant placement - 6 months after implant placement

Secondary Outcomes

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).

Time frame: Baseline, 1 month, 3 months, and 6 months.

Data from ClinicalTrials.gov

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