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

Ain Shams University

Status: Enrolling

Conditions: Partial Edentulism Class II; Dental Implants; Implant

Treatments: Device: Implant-Supported Zirconia Fixed Partial Denture.; Device: Cobalt Chromium Removable Partial Denture; Device: Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture

Study type: Interventional

Funder types: Other

Identifiers

NCT06150768

FDASU-RecIM 092305

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 estimated patients

Sex: All

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Control group Cobalt Chromium Removable Partial Denture

Active Comparator group

Description:

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.

Treatment:

Device: Cobalt Chromium Removable Partial Denture

Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture

Experimental group

Description:

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

Treatment:

Device: Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture

Implant-Supported Zirconia fixed partial denture

Experimental group

Description:

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

Treatment:

Device: Implant-Supported Zirconia Fixed Partial Denture.