Silicate β-TCP vs Extended Sticky Bone for Peri-Implant Jumping Gap in Guided Immediate Implants: RCT

Mansoura University72 enrolled

Overview

This randomized clinical trial compares three peri-implant jumping gap management approaches following fully guided immediate implant placement in the maxillary esthetic zone. Clinical and digital outcomes will be evaluated after immediate provisionalization and final restoration.

Seventy two patients will be randomly assigned to receive no graft, silicate-added β-TCP putty, or extended sticky bone for jumping gap management around immediately placed implants. A CAD/CAM provisional crown will be delivered immediately, and the final prosthesis will be placed after 3 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Interventions

No GraftingPROCEDURE

The peri-implant jumping gap was managed without grafting.

Silicate-Added β-TCP PuttyPROCEDURE

The peri-implant jumping gap was managed using silicate-added β-TCP putty.

Extended Sticky BonePROCEDURE

The peri-implant jumping gap was managed using extended sticky bone.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with non-restorable teeth in maxillary esthetic zone requiring dental extraction. * Age range: from18 to 50 years. * 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.

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: - 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.