Porcelain-fused-to-metal Versus Zirconia Implant- Supported in Mandibular Kennedy Class II

Study Overview
=================
Brief Summary
-----------------
The goal of this randomized clinical trial is to compare biting force and patient satisfaction in three groups. Patients in the control group number one will receive a CoCr removable partial denture, and in the other two groups, implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area. After three months, implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two, while in group number three, implants will be loaded with three units of anatomical Zirconia-fixed partial dentures. Biting force will be measured bilaterally at the time of delivery of the removable partial denture and delivery of fixed partial dentures after two, four, and six months. Patient satisfaction will be assessed through a quality-of life questionnaire at the six-months recall appointment

Detailed Description
-----------------
Thirty-three partially edentulous patients will be recruited. Patients will be randomly divided into three groups. Patients in the control group number one will receive a CoCr removable partial denture; in the other two groups, implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area using a two-stage surgical technique with the help of a radiographic and surgical stent. Pre-surgical and post-surgical prescription of antibiotics, anti-inflammatory drugs, analgesic drugs, and mouthwash for one week, then a follow-up will be done at the suture removal appointment. After a three-month osseointegration period, implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two, while in group number three, implants will be loaded with three units of anatomical Zirconia-fixed partial dentures. Recall appointments will be scheduled for the patients two, four, and six months after loading for the collection of the data. Biting force will be measured using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture and at the loading of implants after two, four, and six months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the six-months recall appointment.

Official Title
-----------------
Biting Force and Quality of Life in Porcelain-fused-to Metal Versus Zirconia Implant- Supported in Mandibular Kennedy Class II ( In Vivo Study )

Conditions
-----------------
Partial Edentulism Class II, Dental Implants, Implant

Intervention / Treatment
-----------------
* Device: Cobalt Chromium Removable Partial Denture
* Device: Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture
* Device: Implant-Supported Zirconia Fixed Partial Denture.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kennedy Class II mandibular arch where the last standing abutment is the first premolar, opposed by a fully dentate maxilla (either natural dentition or fixed prostheses). A minimum of 12 millimeters of bone height above the inferior alveolar canal diagnosed from the pre-operative cone beam CT. Sufficient inter-arch space to accommodate the implant supported fixed partial denture. Exclusion Criteria: Patients with bone or mucosal diseases. Heavy smokers. Patients with uncontrolled metabolic disorders such as diabetes mellitus. Patients with parafunctional habits. Patients with conditions that might complicate the treatment, such as: severe gag reflex, limited mouth opening.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group (1) will receive a CoCr removable partial denture; in the other two groups (2) and (3), implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area using a two-stage surgical technique with the help of a radiographic and surgical stent. After a three-month osseointegration period, implants will be loaded with three units of anatomical PFM fixed partial dentures in group (2), while in group (3), implants will be loaded with three units of anatomical Zirconia fixed partial dentures. Biting force will be measured using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture and at loading of implants, after 2, 4, and 6 months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the recall appointments.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group Cobalt Chromium Removable Partial Denture<br>The patient will receive a Cobalt Chromium Removable Partial Denture to restore missing posterior teeth in Kennedy Class II cases. The denture will be fabricated by conventional lost-wax and processing techniques. | Device: Cobalt Chromium Removable Partial Denture<br>* The patient will receive Removable Partial Denture to restore missing teeth in Kennedy Class II cases.<br>* Other names: Combined Removable Partial denture.;|
| Experimental: Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture<br>Two dental implants will be placed to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in Kennedy Class II cases by using a two-stage surgical technique with the help of a radiographic and surgical stent. After a three-month osseointegration period, implants will be loaded with three units of anatomical Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture | Device: Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture<br>* The patient will receive Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture to restore missing teeth in Kennedy Class II cases.<br>* Other names: : Implant-Supported Porcelain-Fused-to-Metal-Fixed bridge;|
| Experimental: Implant-Supported Zirconia fixed partial denture<br>Two dental implants will be placed to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in Kennedy Class II cases by using a two-stage surgical technique with the help of a radiographic and surgical stent. After a three-month osseointegration period, implants will be loaded with three units of anatomical implant-supported Zirconia fixed partial dentures | Device: Implant-Supported Zirconia Fixed Partial Denture.<br>* The patient will receive Implant-Supported Zirconia Fixed Partial Denture to restore missing teeth in Kennedy Class II cases.<br>* Other names: Implant-Supported Zirconia Fixed bridge.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of biting force | improvement of Biting force in two different implants supported partial dentures. | Biting force will be measured by newtons unit per minute using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture ( baseline ) and at loading of implants, after 2, 4, and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health-related quality of life ( OHRQoL ) Measurement | OHRQoL was measured by using the original version of the Oral Health Impact Profile OHIP-14, which has been shown to be valid and reliable. The questionnaire included sevendomains-functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap-with two questions each. For each item responses were never, hardly ever, occasionally, fairly often and very often. Items were scored on a 5-point scale ranging from 0 (never), to 1 (hardly ever), 2 (occasionally), 3 (fairly often) and 4 (very often) | At the time of delivery of the removable partial denture ( baseline ) and at loading of implants, after 2, 4, and 6 months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the recall appointments. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Implants, Edentulous, partially, dental prosthesis, implant-supported, fixed partial denture