Two Versus Four Implant-supported Fixed Full-arch Prosthesis

Prosthesis Durability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290766
• Other study ID #: A03040122
• Status: Completed
• Phase: N/A
• Start date: January 4, 2020
• Est. completion date: April 16, 2023

Study information

• Verified date: April 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 16, 2023
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis Durability
• Prosthesis Failure

Intervention

Procedure:
• placement of four dental implants
placement of four dental implants according to the " All on four concept"
• placement of two dental implants
placement of two dental implants according to " All on two concepts"

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

Locations

Country	Name	City	State
Egypt	Christine Ibrahim	Mansoura
Egypt	Faculty of Dentistry, Mansoura University	Mansoura	Eldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	crestal bone loss	measuring marginal bone loss in mm around dental implants by digital radiography	one year
Primary	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
Primary	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
Primary	pocket depth	evaluation of pocket depth in mm around dental implants	one year
Secondary	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
Secondary	prosthesis maintenance and survival rate	measuring the survival rate of the mandibular prosthesis in both groups	one year