ClinicalTrials.gg
RecruitingNCT06422260Updated May 20, 2024

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

An observational study in Prosthesis Survival and Bone Loss, sponsored by Menoufia University. Recruiting at 1 site in Egypt. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-05-20.

Sponsored by Menoufia University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
30 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region.

02

Conditions studied

  • Prosthesis Survival
  • Bone Loss
03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 60 is below the median of 119 across 49 observational studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Grade 1 or 2 mobility at the incisor's region.
  • Patients with systematic diseases that contraindicate implant placement.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherProsthesis superstructure

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

06

What researchers measure

Primary outcomes

  1. Bone loss

    Measurement of alveolar bone loss around implants.

    Time frame: 4 years

Secondary outcomes

  1. Clinical performance of the prosthesis superstructure

    Such as fracture of the prosthesis.

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — The result can be shared upon request from the corresponding author

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Jul 2024, 18 months after the start.

Of 28 observational studies under Prosthesis Failure, half reached primary completion within 181 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 184. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2024
First posted
May 20, 2024
StartActual
Jan 19, 2023
Primary completionEst.
Jul 22, 2024
CompletionEst.
Jan 29, 2025
Last update
May 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06422260
Responsible party
Mohammed El-Sawy (lecturer, Department of prosthodontics, principle investigator, Menoufia University) — Principal investigator
First posted
May 20, 2024
Start date
Jan 19, 2023
Primary completion
Jul 22, 2024 (estimated)
Completion
Jan 29, 2025 (estimated)
Last update
May 20, 2024

Study contacts

Mohammed A. El-Sawy, PhD
Contact
Dr_sawy@windowslive.com
01061314522
Mohammed T. Khater, PhD
Contact
mohamed.tarek67@dent.menofia.edu.eg
01003854552
Mohammed A. El-Sawy, PhD
principal investigator · Menoufia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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