Clinical trial NCT06150768: Porcelain-fused-to-metal Versus Zirconia Implant- Supported in Mandibular Kennedy Class II
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 )
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Partial Edentulism Class II
Dental Implants
Implant
Keywords: Dental Implants
Edentulous
partially
dental prosthesis
implant-supported
fixed partial denture
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluation of biting force
timeFrame: 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 outcomes:
measure: Oral health-related quality of life ( OHRQoL ) Measurement
timeFrame: 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.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
affiliation: Faculty of Dentistry Ain Shams University
name: Ingy T Lebshtien, PHD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry Ain Shams University
name: Noha M El Hussieny, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry Ain Shams University
name: Omnia MS Refai, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry Ain Shams University
name: Ali M Fouda
role: PRINCIPAL_INVESTIGATOR
References:
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