Two Versus Four Implant-supported Fixed Full-arch Prosthesis

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

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.

Study Overview

• Status: Completed
• Conditions: Prosthesis Durability
• Intervention / Treatment: Procedure: placement of four dental implants; Device: mandibular full arch prosthesis; Procedure: placement of two dental implants

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".

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, P.O.Box:35516
    • Christine Ibrahim
  • Eldakahlia
    • Mansoura, Eldakahlia, Egypt, 35516
      • Faculty of Dentistry, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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; placement of four dental implants according to the " All on four concept"; Device: mandibular full arch prosthesis; loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis
Active Comparator: Study group; will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".	Device: mandibular full arch prosthesis; loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis; Procedure: placement of two dental implants; placement of two dental implants according to " All on two concepts"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
crestal bone loss	measuring marginal bone loss in mm around dental implants by digital radiography	one year
plaque index	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	one year
gingival index	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.	one year
pocket depth	evaluation of pocket depth in mm around dental implants	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2020
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): April 16, 2023

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: A03040122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No