Retention, Chewing Efficiency and Masticatory Performance of Partial Dentures Opposing Implant Retained Prosthesis.

Sponsor

National Research Centre, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT05999760

Collaborator

(none)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Implant Site Reaction Implant Complication	Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge Device: chewing efficiency by electromyograph(E.M.G) Other: masticatory performance(questionnaire)	N/A

Detailed Description

in this study 22 patients will be selected following inclusion and exclusion criteria. The patients will be divided randomly into two groups.

Group I patients will receive Versacrylic removable partial denture. group II patients will receive CAD/CAM removable partial denture all patients will be given the home care instructions at night and brush cleaning of the dentures.

Measurements of retention using universal testing machine, masticatory performance using T-scan III computerized system and chewing efficiency using chewing function questionnaire

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

each patient was not informed about material of received prosthesis

Primary Purpose:

Treatment

Official Title:

Retention, Chewing Efficiency and Masticatory Performance of Maxillary Flexible Versus Computer Aided Design/Computer Aided Manufacture(CAD/CAM) Partial Dentures Opposing Fixed Implant Retained Prosthesis.

Actual Study Start Date :

Nov 15, 2022

Actual Primary Completion Date :

Jan 15, 2023

Actual Study Completion Date :

Jan 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I (patients received Versacryle removable partial denture) patients having Kennedy class I received maxillary Versacryle removable partial denture	Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge 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. Device: chewing efficiency by electromyograph(E.M.G) 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. Other: masticatory performance(questionnaire) 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.
Active Comparator: Group II (patients received CAD/CAM fabricated removable partial denture) 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 gauge 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. Device: chewing efficiency by electromyograph(E.M.G) 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. Other: masticatory performance(questionnaire) 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.

Arm

Intervention/Treatment

Active Comparator: Group I (patients received Versacryle removable partial denture)

patients having Kennedy class I received maxillary Versacryle removable partial denture

Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge

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.

Device: chewing efficiency by electromyograph(E.M.G)

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.

Other: masticatory performance(questionnaire)

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.

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

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 gauge

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.

Device: chewing efficiency by electromyograph(E.M.G)

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.

Other: masticatory performance(questionnaire)

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.

Outcome Measures

Primary Outcome Measures

evaluation of change of retention of versacrylic and CAD/CAM partial denture [on day 1 ,1 month and 2months of prosthesis delivery]
measurement of retention of partial dentures made of Versacryle and CAD/CAM technology
evaluation of change of chewing efficiency of versacrylic and CAD/CAM partial denture [on day 1 ,1 month and 2months of prosthesis delivery]
measurement of chewing efficiency of partial dentures made of Versacryle and CAD/CAM technology
evaluation of change of masticatory performance of versacrylic and CAD/CAM partial denture [on day 1,1 month and 2months of prosthesis delivery]
measurement of masticatory performance of partial dentures made of Versacryle and CAD/CAM technology

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Research Centre	Giza		Egypt	12622

Sponsors and Collaborators

National Research Centre, Egypt

Investigators

Principal Investigator: Menatallah Elhotieby, Researcher, National Research Centre, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Menatallah Mohamed Elhotieby, Principle investigator Researcher fixed and removable prosthodontics, National Research Centre, Egypt

ClinicalTrials.gov Identifier:

NCT05999760

Other Study ID Numbers:

Elhotieby.M

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Menatallah Mohamed Elhotieby, Principle investigator Researcher fixed and removable prosthodontics, National Research Centre, Egypt

Retention

Chewing efficiency

Removable Prosthodontics

Study Results

No Results Posted as of Aug 21, 2023