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

NCT ID: NCT06150768

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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Partial Edentulism Class II Dental Implants Implant

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group Cobalt Chromium Removable Partial Denture

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.

Group Type ACTIVE_COMPARATOR

Cobalt Chromium Removable Partial Denture

Intervention Type DEVICE

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

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

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Implant-Supported Zirconia fixed partial denture

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

Group Type EXPERIMENTAL

Implant-Supported Zirconia Fixed Partial Denture.

Intervention Type DEVICE

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

Interventions

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Cobalt Chromium Removable Partial Denture

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

Intervention Type DEVICE

Implant-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.

Intervention Type DEVICE

Implant-Supported Zirconia Fixed Partial Denture.

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

Intervention Type DEVICE

Other Intervention Names

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Combined Removable Partial denture. : Implant-Supported Porcelain-Fused-to-Metal-Fixed bridge Implant-Supported Zirconia Fixed bridge.

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingy T Lebshtien, PHD

Role: STUDY_DIRECTOR

Faculty of Dentistry Ain Shams University

Noha M El Hussieny, PHD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry Ain Shams University

Omnia MS Refai, PHD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry Ain Shams University

Ali M Fouda

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry Ain Shams University

Locations

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Faculty of Dentistry, Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali M Fouda

Role: CONTACT

Phone: 1099662269

Email: [email protected]

Facility Contacts

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Omnia MS Refai, PHD

Role: primary

Ali M Fouda

Role: backup

References

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Bandiaky ON, Lokossou DL, Soueidan A, Le Bars P, Gueye M, Mbodj EB, Le Guehennec L. Implant-supported removable partial dentures compared to conventional dentures: A systematic review and meta-analysis of quality of life, patient satisfaction, and biomechanical complications. Clin Exp Dent Res. 2022 Feb;8(1):294-312. doi: 10.1002/cre2.521. Epub 2022 Jan 11.

Reference Type BACKGROUND
PMID: 35014207 (View on PubMed)

Bural C, Buzbas B, Ozatik S, Bayraktar G, Emes Y. Distal extension mandibular removable partial denture with implant support. Eur J Dent. 2016 Oct-Dec;10(4):566-570. doi: 10.4103/1305-7456.195180.

Reference Type BACKGROUND
PMID: 28042277 (View on PubMed)

Behr M, Zeman F, Passauer T, Koller M, Hahnel S, Buergers R, Lang R, Handel G, Kolbeck C. Clinical performance of cast clasp-retained removable partial dentures: a retrospective study. Int J Prosthodont. 2012 Mar-Apr;25(2):138-44.

Reference Type BACKGROUND
PMID: 22371834 (View on PubMed)

Erkmen E, Meric G, Kurt A, Tunc Y, Eser A. Biomechanical comparison of implant retained fixed partial dentures with fiber reinforced composite versus conventional metal frameworks: a 3D FEA study. J Mech Behav Biomed Mater. 2011 Jan;4(1):107-16. doi: 10.1016/j.jmbbm.2010.09.011. Epub 2010 Oct 1.

Reference Type BACKGROUND
PMID: 21094484 (View on PubMed)

Nazari V, Ghodsi S, Alikhasi M, Sahebi M, Shamshiri AR. Fracture Strength of Three-Unit Implant Supported Fixed Partial Dentures with Excessive Crown Height Fabricated from Different Materials. J Dent (Tehran). 2016 Nov;13(6):400-406.

Reference Type BACKGROUND
PMID: 28243301 (View on PubMed)

Gokcen-Rohlig B, Saruhanoglu A, Cifter ED, Evlioglu G. Applicability of zirconia dental prostheses for metal allergy patients. Int J Prosthodont. 2010 Nov-Dec;23(6):562-5.

Reference Type BACKGROUND
PMID: 21209994 (View on PubMed)

Pelaez J, Cogolludo PG, Serrano B, Serrano JF, Suarez MJ. A four-year prospective clinical evaluation of zirconia and metal-ceramic posterior fixed dental prostheses. Int J Prosthodont. 2012 Sep-Oct;25(5):451-8.

Reference Type BACKGROUND
PMID: 22930766 (View on PubMed)

Gu Y, Bai Y, Xie X. Bite Force Transducers and Measurement Devices. Front Bioeng Biotechnol. 2021 Apr 9;9:665081. doi: 10.3389/fbioe.2021.665081. eCollection 2021.

Reference Type BACKGROUND
PMID: 33898409 (View on PubMed)

Other Identifiers

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FDASU-RecIM 092305

Identifier Type: -

Identifier Source: org_study_id