NCT06620315

Comparison Between Primary and Secondary Implant Stability of Hybrid Versus Resorbable Blast Media (RBM) Surfaces Using Resonance Frequency Analysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

• To compare primary stability (during initial loading of implant) and secondary stability (after 12 weeks of implant loading) which are denoted as ISQ value of Hybrid (DIO UFII) versus Resorbable blast media (RBM) (Osstem TSII) implant surfaces.

Detailed description

An approval from the hospital ethical committee will be obtained for this study. As a protocol all patients presenting to Institute of Dentistry, CMH Lahore Medical College will be examined in general OPD and those patients who fulfill the inclusion and exclusion criteria will be referred to Prosthodontics department. After history, complete oral examination and informed consent. Patients will be divided into two groups by lottery method; In Group 1 Hybrid (sand blasted acid etched implants) will be place. In Group 2 Resorbable Blast Media (RBM) implant surfaces will be placed. On the basis of randomized study the patients will be selected for the study to measure implant primary stability with a resonance frequency analyzer at the time of initial loading of implant, starting with an assessment immediately following implant placement with insertion torque of 30 Ncm and then secondary stability at 12 weeks post operatively by using Ostell Mentor. This instrument on each implant by inserting a standardized abutment (Smartpeg) of fixed length into each implant. The transducer probe (Osstell mentor probe) will be held so that the probe tip was aimed at the small magnet on top of the Smartpeg at a distance of 2-3 mm in both the buccal and lingual directions, and the mean of these measurements will then be calculated. The probe will be held still during the pulsing time until the instrument beeped and the displayed the ISQ value. ISQ1 will be evaluated immediately during initial implant loading which will be primary stability and ISQ2 will be evaluated after 12 weeks of implant placement when implant is properly osseointegrated, which will be secondary stability of an implant. The implant fixtures will be DIO UF II for the Hybrid implants and the Osstem TSII plus system for the RBM implants. Data would be stratified for age, gender and implant site to address the effect modifiers.

Conditions

• Implant Complication
• IMPANT STABILITY

Interventions

Type	Name	Description
COMBINATION_PRODUCT	RBM	Resorbable Blast Media (RBM) implant surfaces can enhance osseointegration and implant stability
COMBINATION_PRODUCT	sand blasted implant	sand blasted implant

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-01
• Completion: 2024-03-01
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated device study