Insertion of Immediate Cortical Satellite Implants With Immediate Loading

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05782634
Collaborator
(none)
6
1
1
14
0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: immediate satellite implant with immediate loading
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Insertion of Immediate Cortical Satellite Implants With Immediate Loading in the Maxillary Esthetic Zone, a Case Series Study
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. final implant stability after satellite implant device removal. [6 months]

    OUT COME Calculate the final implant stability after plate removal. MEASURE DEVICE Osstell "resonance frequency analyzer" MEASURE UNIT ISQ

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university , Giza Egypt

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Esraa Essam Mohamed Mahmoud, master candidate, Cairo University
ClinicalTrials.gov Identifier:
NCT05782634
Other Study ID Numbers:
  • essam95
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 23, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Esraa Essam Mohamed Mahmoud, master candidate, Cairo University

Study Results

No Results Posted as of Mar 23, 2023