Insertion of Immediate Cortical Satellite Implants With Immediate Loading

Insertion of Immediate Cortical Satellite Implants With Immediate Loading in the Maxillary Esthetic Zone, a Case Series Study

Statement of the problem:

Based on the literature traditional immediate implant with immediate loading has high failure rate due to destructive horizontal forces, accordingly It was recommended for long time stress-free healing periods to achieve the osseointegration of dental implants.

But unfortunately this long time to restore the missing teeth is unsatisfactory to the patient due to high increase of patients' demand for perfect restoring missing teeth preservation of soft and hard tissues with better esthetic and functional results with decreasing the treatment plan time.

Rationale for conducting the research:

This study aimed to add a satellite implant device around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant

Study Overview

• Status: Not yet recruiting
• Conditions: Immediate Loading , Satellite Implant , Immediate Implant
• Intervention / Treatment: Device: immediate satellite implant with immediate loading

Detailed Description

Research question:

Does the use of satellite implant technique for immediate loading will effectively reduce the treatment time without affection of the final implant stability and the final bone quality and quantity around the placed root form dental implant?

Statement of the problem:

Based on the literature traditional immediate implant with immediate loading has high failure rate due to destructive horizontal forces, accordingly It was recommended for long time stress-free healing periods to achieve the osseointegration of dental implants.

But unfortunately this long time to restore the missing teeth is unsatisfactory to the patient due to high increase of patients' demand for perfect restoring missing teeth preservation of soft and hard tissues with better esthetic and functional results with decreasing the treatment plan time.

Rationale for conducting the research:

This study aimed to add a satellite implant device around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant

Review of literature:

A long time before there is increase of the patient demand for perfect restoring missing teeth with reducing the total time of treatment over all. So immediate loading implant was a very good solution especially in esthetic zone . However , it is not always applicable due to the difficult surrounding circumcenters Such like unfavorable type or quality of bone which makes immediate implant is impossible. Osseointegration of an implant, which is the main treatment goal, might best be understood to simply mean "undisturbed bone healing around the implant." Micro motion probably interferes with the development of an adequate early scaffold from the fibrin clot . Biomechanically, implants to be loaded immediately need to be stable and resistant to macro movement to ensure good osseointegration. Enhancement of implant stability can be achieved primarily by using a connecting bar as a stabilizer to provide a polygonal support to distribute forces and moments on single standing implants . This study aimed to add a satellite plate around the root form implant to enhance the primary implant stability for immediate loading followed by assessment of the final implant stability and final bone quantity and quality around the placed implant.

Objectives:

This study aimed to evaluate the final implant stability and bone condition after the use of satellite immediate implant with immediate loading in fresh extraction sockets.

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: esraa essam, B.D.S; Phone Number: 01009518350; Email: esraa.essam@dentistry.cu.edu.eg
• Study Contact Backup: Name: Mohammed omaraa, lecturer; Phone Number: 01144452862

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo university ,
    • Contact: cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients seeking implant drive prosthesis after immediate extraction technique .
• Fresh extraction sockets with undestructed labial or palatal walls.
• Patients with non-restorable teeth due to untreatable caries or trauma.

Exclusion Criteria:

• General contraindications to implant surgery.
• Active infection or severe inflammation in the area intended for implant placement
• Teeth non restorable due to periodontal issues.
• Poor oral hygiene and motivation.
• Pregnant or nursing.
• Substance abuse.
• Psychiatric problems or unrealistic expectations.
• Severe bruxism or clenching.
• Immunosuppressed or immunocompromised.
• Treated or under treatment with intravenous amino-bisphosphonates.
• Patients participating in other studies, if the present protocol could not be properly followed

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: subjected to immediate cortical satellite implants with immediate loading; All patients involved in this study will be subjected to immediate cortical satellite implants with immediate loading

Device: immediate satellite implant with immediate loading; Infiltration anesthesia will be administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 . Injection to control pain and bleeding for hemostasis. Dental extraction will be done with minimal force to avoid trauma to the bone. Flab will be released, different drilling sizes will be used to attain the final drill size of the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, a satellite implant device is attached to the implant's abutment placed on the buccal and palatal plates of bone and retention between the abutment and microplate will help in neglecting the lateral destructive forces . sutures will be done . Impression will be taken for immediate loading with the final crown. Cone beam will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
final implant stability after satellite implant device removal.	OUT COME Calculate the final implant stability after plate removal. MEASURE DEVICE Osstell "resonance frequency analyzer" MEASURE UNIT ISQ	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: salah yassin, professor, • Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University; Study Director: Mohammed omaraa, lecturer, • Lecturer in Oral and Maxillofacial Surgery- Cairo University.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: immediate loading , satellite implant , immediate implant
• Other Study ID Numbers: essam95

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No