NCT04793503

Brief Summary

The aim of this study was to compare the MBF and chewing efficiency of complete denture bases fabricated by conventional, 3D printing and milling techniques. The research hypothesis was that, there are no significant differences in MBF and chewing efficiency in complete dentures fabricated by the three methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

January 24, 2021

Last Update Submit

August 31, 2021

Conditions

BitingChewing Problem

Keywords

complete dentureBiting forcechewing efficiencyCAD/CAM

Outcome Measures

Primary Outcomes (1)

  • biting force

    \- This is done custom-made device composed of Flexiforce A 301® force sensor and Arduino microcontroller with a crystal display. The sensor is calibrated by known weight object for several times, and the sensor is covered by 3 mm layer of putty rubber base material. • The device was placed between the upper and lower first molar. The patient then was instructed to bite as hard as possible for a period of 3 s three times in succession, with at least 20 s of resting between each bite. The readings were recorded, and the average bite force was calculated

    Readings will be performed baseline 1 week after denture insertion then 1 month after denture insertion then 3 months after denture insertion.

Secondary Outcomes (1)

  • chewing efficiency

    3 months after denture insertion

Study Arms (3)

conventional complete denture

ACTIVE COMPARATOR

the patients receive conventional complete denture constructed from heat cure acrylic resin

Other: conventional complete denture

CADCAM 3D printed denture

ACTIVE COMPARATOR

the patients receiveCADCAM 3D printed denture constructed by using printing machine

Other: CADCAM 3D printed denture

CAD/CAM milled denture

ACTIVE COMPARATOR

the patients receiveCADCAM 3D printed denture constructed by using milling machine

Other: CAD/CAM milled denture

Interventions

conventional complete dentureOTHER

the complete denture constructed by packing technique

conventional complete denture
CADCAM 3D printed dentureOTHER

The files from the laser-scan will be translated into stereolithography (STL) files and the CDs are virtually designed in ExoCad software

CADCAM 3D printed denture
CAD/CAM milled dentureOTHER

Once the complete denture has been virtually designed in CAD software (ExoCad software) a preview will be sent for evaluation using 3D viewing software

CAD/CAM milled denture

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Angle class I jaw relation maxillomandibular relationship
  • Normal alveolar ridge volume
  • No temporomandibular joint disorders
  • No heart disease
  • No systemic diseases that affect the complete denture treatment procedures

You may not qualify if:

  • Abnormal jaw relation
  • TMJ disorders
  • Any systemic disease interfering with complete denture treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry , Kafr El Shiekh University

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the patient doesn't recognise the type of complete denture that he use
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: To reduce the effect of order of treatment on MBF, were successively given the following prosthesis i) complete dentures fabricated by the conventional technique ii) 3D printed complete dentures iii) milled complete dentures in a random order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of prosthodontics

Study Record Dates

First Submitted

January 24, 2021

First Posted

March 11, 2021

Study Start

February 20, 2020

Primary Completion

November 15, 2020

Study Completion

December 2, 2020

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

mean and standard deviation for each outcome in each group

Shared Documents
STUDY PROTOCOL

Locations

EG(1)