NCT06620315

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 15, 2024

Last Update Submit

September 30, 2024

Conditions

Implant ComplicationIMPANT STABILITY

Outcome Measures

Primary Outcomes (1)

  • Primary Stability

    absence of clinically detectable implant mobility

    up to 3 months

Secondary Outcomes (1)

  • Secondary Stability

    3 months

Study Arms (2)

Hybrid (sand blasted acid etched implants)

ACTIVE COMPARATOR
Combination Product: sand blasted implant

RBM

ACTIVE COMPARATOR

RBM implant

Combination Product: RBM

Interventions

RBMCOMBINATION_PRODUCT

Resorbable Blast Media (RBM) implant surfaces can enhance osseointegration and implant stability

RBM
sand blasted implantCOMBINATION_PRODUCT

sand blasted implant

Hybrid (sand blasted acid etched implants)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;
  • Bone height (minimum of 12mm)
  • Bone width (minimum of 5mm)
  • Proximity with vital structures (nerves, blood vessels)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Prosthodontics, Institute of Dentistry/CMH Lahore Medical College.

Lahore, Punjab Province, 41000, Pakistan

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

August 15, 2024

First Posted

October 1, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

October 1, 2024

Record last verified: 2024-08

Locations

PA(1)