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All on Four Versus All on Three Implant Treatment Concepts

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05912127
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
16.8
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts rehabilitation of atrophied mandibular ridge.

Condition or Disease Intervention/Treatment Phase
  • Device: implant supported fixed full arch prosthesis
 N/A

Detailed Description

Patients will be classified into 2 groups according to the implant treatment concept they received:

  • Group 1 (control group); included patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.

  • Group 2 (test group); included patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be classified into 2 groups according to the implant treatment concept they received: Group 1 (control group); included 3 patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas. Group 2 (test group); included 3 patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.Patients will be classified into 2 groups according to the implant treatment concept they received:Group 1 (control group); included 3 patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas. Group 2 (test group); included 3 patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
All On-4 Versus All o-3 Implant Treatment Concepts for Rehabilitation of Atrophied Mandibular Ridge. A Study of Patient Satisfaction
Actual Study Start Date :
Jan 16, 2022
Actual Primary Completion Date :
Oct 9, 2022
Actual Study Completion Date :
Jun 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: • Group 1 (control group)

patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.

Device: implant supported fixed full arch prosthesis
the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.
Active Comparator: • Group 2 (test group);

patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.

Device: implant supported fixed full arch prosthesis
the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.

Outcome Measures

Primary Outcome Measures

  1. patient satisfaction [one year]

    Patient satisfaction was evaluated using a questionnaire based on visual analog scale (VAS)

  2. crestal bone loss [Two year]

    bone loss was measured around the implants in mm

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts.

  1. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetes or osteoporosis. This was achieved through medical history and clinical examination by the physician.

  2. All patients have sufficient inter-arch space. 4. All patients are of angle class I maxillo-mandibular relationships. 5. All patients had maxillary conventional complete dentures.

Exclusion Criteria:
  1. Any neuromuscular disorders 2. Uncooperative patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Christine Ibrahim Mansoura Egypt P.O.Box:35516

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Principal Investigator: Mostafa Elsyad, professor, professor of prosthodontics, Faculty of dentistry , Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05912127
Other Study ID Numbers:
  • A09071221
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prosthesis Failure

Study Results

No Results Posted as of Jun 22, 2023