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

• 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.

Study Overview

• Status: Completed
• Conditions: Implant Complication; IMPANT STABILITY
• Intervention / Treatment: Combination product: sand blasted implant; Combination product: RBM

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 41000
      • Department of Prosthodontics, Institute of Dentistry/CMH Lahore Medical College.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• o Age between 20 to 50 years.

  • Both male and female patients will be selected.

  • Patients suitable for implant restorations on CBCT will be diagnosed by;

    1. Bone height (minimum of 12mm)
    2. Bone width (minimum of 5mm)
    3. Proximity with vital structures (nerves, blood vessels)

Exclusion Criteria:

• o Patients with diabetes, Parkinson's disease, myasthenia gravis and bulbar palsy

  • Diseases with either a strong connection to emotional stress or impairing mental health like depression, anxiety, sleeping disorder on history examination.
  • Patients with poor oral hygiene.
  • Patients with parafunctional habits of severe clenching habit, bruxism.
  • Heavy smokers
  • Patients who had undergone radiotherapy or chemotherapy.
  • Patients with osteoarthritis, osteoporosis.
  • Patients taking bisphosphonates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hybrid (sand blasted acid etched implants)	Combination product: sand blasted implant; sand blasted implant
Active Comparator: RBM; RBM implant	Combination product: RBM; Resorbable Blast Media (RBM) implant surfaces can enhance osseointegration and implant stability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Stability	absence of clinically detectable implant mobility	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Stability	absence of clinically detectable implant mobility	3 months

Collaborators and Investigators

• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CPSP/REU/DSG-2018-262-2439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes