Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials

NCT06422260 | Recruiting

• 1 other identifier: ADMNF-0030324
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.

Conditions

Prosthesis Survival; Bone Loss

Outcome Measures

Primary Outcomes (1)

• Bone loss

  Measurement of alveolar bone loss around implants.

  4 years

Secondary Outcomes (1)

• Clinical performance of the prosthesis superstructure

  4 years

Study Arms (3)

Porcelin fused to metal (PFM) group

Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PFM

Other: Prosthesis superstructure

Zirconia group

Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from ceramics

Other: Prosthesis superstructure

Polyetheretherketone (PEEK) group

Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PEEK

Other: Prosthesis superstructure

Interventions

Prosthesis superstructure OTHER

Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials

Polyetheretherketone (PEEK) group; Porcelin fused to metal (PFM) group; Zirconia group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone.

You may qualify if:

• No systemic diseases that might alter the tissue response to implantation.
• Mobility grade 3 at the site of the 4 lateral incisors.
• sufficient available inter-arch space
• normal maxillomandibular relation.
• no temporomandibular joint

You may not qualify if:

• Grade 1 or 2 mobility at the incisor's region.
• Patients with systematic diseases that contraindicate implant placement.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Mohammed A. El-Sawy

Al Mansurah, 12345, Egypt

RECRUITING

MeSH Terms

Conditions

Prosthesis Failure; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohammed A. El-Sawy, PhD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed A. El-Sawy, PhD

CONTACT

01061314522; Dr_sawy@windowslive.com

Mohammed T. Khater, PhD

CONTACT

01003854552; mohamed.tarek67@dent.menofia.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, Department of prosthodontics, principle investigator

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 20, 2024
• Study Start: January 19, 2023
• Primary Completion: July 22, 2024
• Study Completion: January 29, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)