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

NCT06150768 | Unknown DMC

• 1 other identifier: FDASU-RecIM 092305
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Partial Edentulism Class II; Dental Implants; Implant

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oral health-related quality of life ( OHRQoL ) Measurement

  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.

Study Arms (3)

Control group Cobalt Chromium Removable Partial Denture

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Implant-Supported Zirconia fixed partial denture

EXPERIMENTAL

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.

Interventions

Cobalt Chromium Removable Partial Denture DEVICE

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

Also known as: Combined Removable Partial denture.

Control group Cobalt Chromium Removable Partial Denture

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

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

Also known as: : Implant-Supported Porcelain-Fused-to-Metal-Fixed bridge

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

Implant-Supported Zirconia Fixed Partial Denture. DEVICE

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

Also known as: Implant-Supported Zirconia Fixed bridge.

Implant-Supported Zirconia fixed partial denture

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, 11566, Egypt

RECRUITING

Related Publications (8)

• 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.

  PMID: 35014207 BACKGROUND

• 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.

  PMID: 28042277 BACKGROUND

• 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.

  PMID: 22371834 BACKGROUND

• 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.

  PMID: 21094484 BACKGROUND

• 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.

  PMID: 28243301 BACKGROUND

• 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.

  PMID: 21209994 BACKGROUND

• 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.

  PMID: 22930766 BACKGROUND

• 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.

  PMID: 33898409 BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Ingy T Lebshtien, PHD

  Faculty of Dentistry Ain Shams University

  STUDY DIRECTOR

• Noha M El Hussieny, PHD

  Faculty of Dentistry Ain Shams University

  PRINCIPAL INVESTIGATOR

• Omnia MS Refai, PHD

  Faculty of Dentistry Ain Shams University

  PRINCIPAL INVESTIGATOR

• Ali M Fouda

  Faculty of Dentistry Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali M Fouda

CONTACT

1099662269; Ali_fouda97@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The IPD will be available after the end of the study, and it will be available for 12 months after the publication date of the study.

Locations

EG (1)