A Phase 4 interventional study of RBM and sand blasted implant in Implant Complication and IMPANT STABILITY, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Phase 4, Interventional, and Supportive care
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.
Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
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o Age between 20 to 50 years.
Patients suitable for implant restorations on CBCT will be diagnosed by;
Exclusion Criteria:
o Patients with diabetes, Parkinson's disease, myasthenia gravis and bulbar palsy
Combination Product: sand blasted implant
RBM implant
Combination Product: RBM
Resorbable Blast Media (RBM) implant surfaces can enhance osseointegration and implant stability
sand blasted implant
Primary Stability
absence of clinically detectable implant mobility
Time frame: up to 3 months
Secondary Stability
absence of clinically detectable implant mobility
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Shaheed Zulfiqar Ali Bhutto Medical University