Two Versus Four Implant-supported Fixed Full-arch Prosthesis

Not Applicable

Completed

• Conditions: Prosthesis Durability
• Interventions: Procedure: placement of four dental implants; Procedure: placement of two dental implants; Device: mandibular full arch prosthesis

• Registration Number: NCT05290766
• Lead Sponsor: Mansoura University

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.

Detailed Description

* 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

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-01-04
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-22
• Primary Completion: 2022-11-07
• Status Verified: 2023-04
• Study Completion: 2023-04-16
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	placement of four dental implants	will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
Study group	placement of two dental implants	will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".
Study group	mandibular full arch prosthesis	will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".
Control group	mandibular full arch prosthesis	will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".

Primary Outcome Measures

Name	Time	Method
crestal bone loss	one year	measuring marginal bone loss in mm around dental implants by digital radiography
gingival index	one year	evaluation of gingival bleeding using scoring system as following: scores.0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding.
Visual analog scale (VAS) questionnaire	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
plaque index	one year	evaluation of plaque accumulation around dental implants using scores.score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter
pocket depth	one year	evaluation of pocket depth in mm around dental implants

Secondary Outcome Measures

Name	Time	Method
Quality of Life (Secondary Outcome).	one year	The oral Health impact profile (OHIP-14) questions were utilized to assess OHRQoL. The questions were composed of seven domains
prosthesis maintenance and survival rate	one year	measuring the survival rate of the mandibular prosthesis in both groups

Trial Locations

Locations (2)

Faculty of Dentistry, Mansoura University; 🇪🇬 Mansoura, Eldakahlia, Egypt

Christine Ibrahim; 🇪🇬 Mansoura, Egypt