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

NCT ID: NCT06486311

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2027-05-31

Brief Summary

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.

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.

Conditions

Novel Implant for Immediate Load in Posterior Mandible

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

satellite implant

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Tallah Selim Labib Kaream

dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr.hesham shalakamy, lecturer

Role: PRINCIPAL_INVESTIGATOR

• Lecturer of Oral and Maxillofacial Surgery- Cairo University

Locations

Aya Tallah Selim Labib Kaream

Cairo, Shrouk, Egypt

Countries

Egypt

Central Contacts

aya tallah selim labib, master

Role: CONTACT

aya.kaream@dentistry.cu.edu.eg

01143872045

Dr.mohamed khashaba, professor

Role: CONTACT

01227754765

Facility Contacts

aya tallah selim labib, master

Role: primary

aya.kaream@dentistry.cu.edu.eg

01143872045

References

Engelke W, Stahr S, Schwarzwaller W. Enhancement of primary stability of dental implants using cortical satellite implants. Implant Dent. 2002;11(1):52-7. doi: 10.1097/00008505-200201000-00014.

Reference Type: BACKGROUND

PMID: 11915545 (View on PubMed)

Engelke W, Decco OA, de las Mercedes Capobianco M, Schwarzwaller W, Villavicencio MM. Immediate occlusal loading of freestanding implants using cortical satellite implants: preliminary report of a prospective study. Implant Dent. 2005 Mar;14(1):50-7. doi: 10.1097/01.id.0000154796.97355.2d.

Reference Type: BACKGROUND

PMID: 15764945 (View on PubMed)

Other Identifiers

satellite implant

Identifier Type: -

Identifier Source: org_study_id