Two Versus Four Implant-supported Fixed Full-arch Prosthesis

NCT05290766 | Completed

• 1 other identifier: A03040122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS) questionnaire

  Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance

  one year

Secondary Outcomes (1)

• Quality of Life (Secondary Outcome).

  one year

Study Arms (2)

Control group

ACTIVE COMPARATOR

will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".

Procedure: placement of four dental implants; Device: mandibular full arch prosthesis

Study group

ACTIVE COMPARATOR

will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".

Procedure: placement of two dental implants; Device: mandibular full arch prosthesis

Interventions

placement of four dental implants PROCEDURE

placement of four dental implants according to the " All on four concept"

Control group

placement of two dental implants PROCEDURE

placement of two dental implants according to " All on two concepts"

Study group

mandibular full arch prosthesis DEVICE

loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis

Control group; Study group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I

You may not qualify if:

• systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Faculty of Dentistry, Mansoura University

Al Mansurah, Eldakahlia, 35516, Egypt

Location

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 Design

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

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 22, 2022
• Study Start: January 4, 2022
• Primary Completion: November 7, 2022
• Study Completion: April 16, 2023
• Last Updated: January 17, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)