NCT05999760

Brief Summary

This study aims to evaluate retention ,chewing efficiency and masticatory performance of flexible versus CAD/CAM partial dentures opposing to fixed implant retained restorations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 6, 2023

Last Update Submit

August 13, 2023

Conditions

Implant Site ReactionImplant Complication

Keywords

RetentionChewing efficiencyRemovable Prosthodontics

Outcome Measures

Primary Outcomes (3)

  • evaluation of change of retention of versacrylic and CAD/CAM partial denture

    measurement of retention of partial dentures made of Versacryle and CAD/CAM technology

    on day 1 ,1 month and 2months of prosthesis delivery

  • evaluation of change of chewing efficiency of versacrylic and CAD/CAM partial denture

    measurement of chewing efficiency of partial dentures made of Versacryle and CAD/CAM technology

    on day 1 ,1 month and 2months of prosthesis delivery

  • evaluation of change of masticatory performance of versacrylic and CAD/CAM partial denture

    measurement of masticatory performance of partial dentures made of Versacryle and CAD/CAM technology

    on day 1,1 month and 2months of prosthesis delivery

Study Arms (2)

Group I (patients received Versacryle removable partial denture)

ACTIVE COMPARATOR

patients having Kennedy class I received maxillary Versacryle removable partial denture

Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gaugeDevice: chewing efficiency by electromyograph(E.M.G)Other: masticatory performance(questionnaire)

Group II (patients received CAD/CAM fabricated removable partial denture)

ACTIVE COMPARATOR

patients having Kennedy class I received maxillary CAD/CAM fabricated removable partial denture

Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gaugeDevice: chewing efficiency by electromyograph(E.M.G)Other: masticatory performance(questionnaire)

Interventions

evaluation of retention of Versacryle and CAD/CAM partial dentures by force gaugeDEVICE

Evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.

Group I (patients received Versacryle removable partial denture)Group II (patients received CAD/CAM fabricated removable partial denture)
chewing efficiency by electromyograph(E.M.G)DEVICE

Evaluation of chewing efficiency of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.

Group I (patients received Versacryle removable partial denture)Group II (patients received CAD/CAM fabricated removable partial denture)
masticatory performance(questionnaire)OTHER

Evaluation of masticatory performance of Versacryle and CAD/CAM partial dentures by questionnaire on day one, on first month, and on the second month of prosthesis delivery.

Group I (patients received Versacryle removable partial denture)Group II (patients received CAD/CAM fabricated removable partial denture)

Eligibility Criteria

Age40 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoker male Patients
  • Age ranging from 40-50 years.
  • Highly cooperative and motivated patients.
  • Patients Systemically free from any immunosuppressive diseases.
  • Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.
  • Patients not receiving any Radiotherapy or chemotherapy treatment.

You may not qualify if:

  • Female patients
  • Smoker patients.
  • Age exceeding 50 years
  • Uncooperative and unmotivated patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre

Giza, 12622, Egypt

Location

Study Officials

  • Menatallah Elhotieby, Researcher

    National Research Centre, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
each patient was not informed about material of received prosthesis
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator Researcher fixed and removable prosthodontics

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 21, 2023

Study Start

November 15, 2022

Primary Completion

January 15, 2023

Study Completion

January 20, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

EG(1)