Two Versus Four Implant-supported Fixed Full-arch Prosthesis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prosthesis Durability

Intervention / Treatment
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* Procedure: placement of four dental implants
* Procedure: placement of two dental implants
* Device: mandibular full arch prosthesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* placement of four dental implants according to the  All on four concept<br>Device: mandibular full arch prosthesis<br>* loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis<br>|
| Active Comparator: Study group<br>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<br>* placement of two dental implants according to  All on two concepts<br>Device: mandibular full arch prosthesis<br>* loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis<br>|

What is the study measuring?
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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 |