Skip to main content
OpenTrials
Completed

NCT Number: NCT05290766

Two Versus Four Implant-supported Fixed Full-arch Prosthesis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prosthesis Durability Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University, Al Mansurah, Eldakahlia, Egypt

Loading trial locations.

About this study

  • Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department
  • All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.

The patients will be divided into 2 groups

  • Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
  • Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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

Exclusion criteria

  • 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.

Treatment and study plan

placement of four dental implants

Procedure

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

placement of two dental implants

Procedure

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

mandibular full arch prosthesis

Device

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

Primary outcomes

  1. Visual analog scale (VAS) questionnaire

    Time frame: one year

    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

Secondary outcomes

  1. Quality of Life (Secondary Outcome).

    Time frame: one year

    The oral Health impact profile (OHIP-14) questions were utilized to assess OHRQoL. The questions were composed of seven domains

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Two Versus Four Implant Supporting Fixed Full-arch Screw-retained Metal Acrylic Hybrid Mandibular Prosthesis.(A Study of Patient Satisfaction)

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 22, 2022
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.