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BitingNCT04793503

Biting Force and Chewing Efficiency of Complete Dentures.

A study testing conventional complete denture, CADCAM 3D printed denture and CAD/CAM milled denture in people with Biting and Chewing Problem, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Biting, Chewing Problem
What is being tested?
conventional complete denture, CADCAM 3D printed denture and CAD/CAM milled denture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteEgypt
Study dates
20 Feb 2020to 2 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry , Kafr El Shiekh University

    Kafr ash Shaykh

Other trials in Egypt

About this study

Official title: Biting Force and Chewing Efficiency of Conventional and CAD/CAM Complete Dentures: A Cross-over Study

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.

Read the detailed description

Participant selection and treatment This study will include a clinical experiment with a cross-over clinical trial design. For this study, 27completely edentulous participants with age range of 50-65 were selected from the outpatient clinic of the Removable Prosthodontic Department, Faculty of dentistry, Kafr Elsheikh University, Egypt. All participants had Angle class I jaw relation maxillomandibular relationship, normal alveolar ridge volume, no temporomandibular joint disorders, no heart disease, and no systemic diseases that affect the complete denture treatment procedures.

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.

Construction of the CADCAM 3D printed denture The same steps of the conventional technique will be performed till the adjustment of occlusion rims then in the dental laboratory, the maxillary and mandibular definitive casts and the occlusal rims will be prepared for scanning with scan spray. Scanning will be performed with an optical 3D scanner . The files from the laser-scan will be translated into stereolithography (STL) files and the CDs are virtually designed in ExoCad software. After minor modifications in the positions of teeth were made, fabrication of the dentures will be approved and the digital denture base will be fabricated using 3D printing technique from Dental Pink resin

Construction of the CAD/CAM milled denture Once the complete denture has been virtually designed in CAD software (ExoCad software) a preview will be sent for evaluation using 3D viewing software. After minor modifications in the positions of teeth were made, fabrication of the dentures will be approved. The digital denture will be fabricated by the command software of the milling machine (ExoCad 5x milling machine) from prepolymerized resin acrylic pucks and the teeth (TSM Acetal Dental) were milled into template .After that the denture will be finished and polished according to the traditional procedures For all groups, after placement, clinical evaluations of the fit, retention, stability, occlusal relationship, esthetics, and phonetics were performed. Assessment of the occlusion was made with articulating paper, chairside adjustments were made and premature contacts were corrected. The patient was given a proper program for denture insertion and oral hygiene measures.

Assessment of biting force

  • This will be made by using a 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.
  • Readings will be performed at 1 week, 1 month and 3 months follow-up periods. Assessment of chewing efficiency The chewing efficiency will be evaluated according to the procedure described by Schimmel et al. (2007) using a chewing gum. Specimens will be prepared from two colored gums one with the flavor "Sour Berry" (white color) and the other with the flavor "Fancy Fruit" (orange color). Two strips of a standard size (30 9 18 9 3 mm) will be cut from each gum and manually stuck together. Patients will be instructed to chew five samples of gum on their preferred chewing side for 5, 10, 20, 30 and 50 cycles, respectively. Between the different tests, an interval of at least 1 min will be imposed to reduce the effect of fatigue. The total duration of the experiments was approximately 8 min.

After chewing, the samples will be then spat into transparent plastic bags, which The samples will be then scanned from both sides with a of resolution 500 dots per inch. The numbers of selected pixels will be recorded from the histogram for each side, and mean of those figures will be calculated. To assess the reproducibility of chewing, the subjects will be available to repeat the experiments on a different day.

Being tested
conventional complete denture, CADCAM 3D printed denture, CAD/CAM milled denture
Keywords
complete denture, Biting force, chewing efficiency, CAD/CAM
Medical subject headings
Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional complete dentureOther

    the complete denture constructed by packing technique

  • 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

  • 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

Study groups in NCT04793503
Study groupRoleWhat they receive
conventional complete dentureActive comparatorthe patients receive conventional complete denture constructed from heat cure acrylic resin
Receives: Other: conventional complete denture
CADCAM 3D printed dentureActive comparatorthe patients receiveCADCAM 3D printed denture constructed by using printing machine
Receives: Other: CADCAM 3D printed denture
CAD/CAM milled dentureActive comparatorthe patients receiveCADCAM 3D printed denture constructed by using milling machine
Receives: Other: CAD/CAM milled denture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)
  1. chewing efficiency

    Specimens will be prepared from two colored gums one with the flavor "Sour Berry" (white color) and the other with the flavor "Fancy Fruit" (orange color). Two strips of a standard size (30 9 18 9 3 mm) will be cut from each gum and manually stuck together.

    Measured: 3 months after denture insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start20 Feb 2020
  3. Primary completion15 Nov 2020
  4. Study completion2 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04793503
Sponsor's protocol ID
KD/07/21
Status last verified
Aug 2021
First submitted
24 Jan 2021
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: mean and standard deviation for each outcome in each group

Questions about this trial

What is this clinical trial studying?

A study testing conventional complete denture, CADCAM 3D printed denture and CAD/CAM milled denture in people with Biting and Chewing Problem, run by Kafrelsheikh University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

biting force (time frame: Readings will be performed baseline 1 week after denture insertion then 1 month after denture insertion then 3 months after denture insertion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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