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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06150768
Enrollment
33
Registered
2023-11-29
Start date
2023-11-01
Completion date
2025-01-31
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants, Implant, Partial Edentulism Class II

Keywords

Dental Implants, Edentulous, partially, dental prosthesis, implant-supported, fixed partial denture

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.

Interventions

The patient will receive Removable Partial Denture to restore missing teeth in Kennedy Class II cases.

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

The patient will receive Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture to restore missing teeth in Kennedy Class II cases.

DEVICEImplant-Supported Zirconia Fixed Partial Denture.

The patient will receive Implant-Supported Zirconia Fixed Partial Denture to restore missing teeth in Kennedy Class II cases.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of biting forceBiting 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.improvement of Biting force in two different implants supported partial dentures.

Secondary

MeasureTime frameDescription
Oral health-related quality of life ( OHRQoL ) MeasurementAt 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.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)

Countries

Egypt

Contacts

Primary ContactAli M Fouda
Ali_fouda97@yahoo.com1099662269

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026