Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible

February 7, 2025 updated by: Aya Tallah Selim Labib Kaream, Cairo University
The research aims to evaluate the long-term effectiveness of satellite implants in the posterior mandible by assessing the levels of crestal bone after six months of first loading and secondary stability issues at fourth-month , primary stability at time of implant loading . In particular, the primary outcome of this study is to assessment stability of satellite implants, which will be evaluated by anycheck device.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

satellite dental implants show potential for improving stability, and reducing crestal bone loss in the posterior mandible site, it offers effective solution for cases where primary stability is compromised due to poor bone quality or quantity. By providing additional support and anchorage, they enhance the overall stability of the implant, reducing the risk of failure and allowing for successful immediate loading. clinical evidence for their efficacy is still lacking. This prospective case series intends to fill this gap by evaluating crestal bone levels and stability factors in patients who are getting satellite implants for immediate loading in the posterior mandible. The results will improve clinical recommendations and practice for implant placements in the posterior mandible.

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr.mohamed khashaba, professor
  • Phone Number: 01227754765

Study Locations

  • Egypt
    • Shrouk
      • Cairo, Shrouk, Egypt, 4914085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients requiring implants for the posterior mandible.
  • Patients aged between 18-45 years old.
  • Implants must be at least 8mm in length.
  • A sufficient quantity and distribution of implants to enable cross-arch stability.
  • Implants must have good initial stability, with insertion torques ranging from 35 to 50 N/cm.
  • Sufficient bone for implant placement and plate fixation.
  • Patient able to give informed consent.
  • Sufficient inter-arch space.

Exclusion Criteria:

  • Contraindications to implant surgery in general.
  • Bruxism.
  • Immunosuppression.
  • History of radiation to the head and neck region.
  • Uncontrolled diabetes.
  • Heavy smokers (more than ten cigarettes per day).
  • Poor oral hygiene.
  • Current or previous bisphosphonate therapy.
  • Substance abuse.
  • Mental illness.
  • Failure to complete 6-month follow-up.
  • Pregnancy or breastfeeding.
  • Insertion torque of less than 35 N/cm.
  • Removal of interim repair during the osseointegration stage.
  • Patients suffering from parafunctional behaviors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assessment stability of satellite implant
Satellite implant is connecting microplate is attached to the implant's supra structure placed on the adjacent alveolus. Miniature "satellite" implant screws are inserted at approximal cortical sites to give the implant additional stability
Procedure: satellite implant
Satellite implant is a additional holding component as a stabilizer to provide a polygonal support to distribute forces and moments on single-standing implants give the implant sufficient resistance to withstand masticatory forces or at least keep it in a stable position during an unloaded healing period to achieve stabilization and subsequent osseointegration of implants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Time Frame: Immediately post-implantation
After the insertion of the satellite implant, primary stability will be assessed at the time of implant loading using the "AnyCheck" device (Neo Biotech, Seoul, Korea). Introduced in 2017, the AnyCheck device evaluates implant stability through a damping capacity assessment method. It functions by striking the healing abutment six times over a span of three seconds. The contact duration between the impacting rod and the healing abutment is measured and converted into Implant Stability Test (IST) values. These values are quantified on a scale from 1 to 99, where higher IST values indicate greater implant stability or lower mobility. This quantitative measure provides a precise, reproducible method to assess the outcome of implant stability immediately after placement.
Immediately post-implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Time Frame: The secondary stability is assessed four months post-implantation for each patient.

Assessment Tool: Secondary stability will be assessed using the "AnyCheck" device (Neo Biotech, Seoul, Korea). Introduced in 2017, this device specifically measures the damping capacity to evaluate implant stability.

Method: After the removal of the satellite implant four months post-procedure, the AnyCheck device will be employed to measure the secondary stability. The device operates by striking the healing abutment six times over a three-second period. The duration of contact between the impacting rod and the healing abutment is recorded.

Measurement Scale: The recorded contact time is then converted into Implant Stability Test (IST) values, which are displayed on a scale from 1 to 99. Higher IST values indicate greater implant stability, reflecting lower mobility of the implant within the bone.
The secondary stability is assessed four months post-implantation for each patient.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Stability Using Satellite Implant for Immediate Loading in Posterior Mandible
Time Frame: Crestal bone loss will be assessed at baseline (immediately post-implantation) and six months after the implant procedure. This timeframe allows for the monitoring of early bone remodeling and loss around the satellite implant.

Measurement Tool: CBCT combined with calibrated dental software.

Method: Crestal bone level will be precisely measured by assessing the interproximal height of bone. This is defined as the distance between the apical end of the first thread of the implant and the most coronal point of the interproximal crestal bone, both buccally and lingually. Measurements will be taken using digital periapical radiographs, which provide high-resolution images allowing for accurate assessment of bone levels.

Data Analysis: The height of the crestal bone will be recorded in millimeters. For each implant, the mean of the buccal and lingual bone heights will be calculated to determine the average crestal bone loss.

Measurement Scale: Measurements will be recorded in millimeters to provide a precise quantitative assessment of bone loss.
Crestal bone loss will be assessed at baseline (immediately post-implantation) and six months after the implant procedure. This timeframe allows for the monitoring of early bone remodeling and loss around the satellite implant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Dr.hesham shalakamy, lecturer, • Lecturer of Oral and Maxillofacial Surgery- Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

June 22, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

June 22, 2024

First Submitted That Met QC Criteria

June 30, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • satellite implant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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