All on Four Versus All on Three Implant Treatment Concepts

NCT05912127 | Completed

• 1 other identifier: A09071221
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (2)

• patient satisfaction

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

  one year

• crestal bone loss

  bone loss was measured around the implants in mm

  Two year

Study Arms (2)

• Group 1 (control group)

ACTIVE COMPARATOR

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

• Group 2 (test group);

ACTIVE COMPARATOR

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

Interventions

implant supported fixed full arch prosthesis DEVICE

the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.

• Group 1 (control group); • Group 2 (test group);

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts.
• \. 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.
• \. 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.

You may not qualify if:

• \. Any neuromuscular disorders 2. Uncooperative patients

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Christine Ibrahim

Al Mansurah, P.O.Box:35516, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mostafa Elsyad, professor

  professor of prosthodontics, Faculty of dentistry , Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: January 16, 2022
• Primary Completion: October 9, 2022
• Study Completion: June 11, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

EG (1)