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.
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.
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.
- Conditions
- Biting, Chewing Problem
- 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 group | Role | What they receive |
|---|---|---|
| conventional complete denture | Active comparator | the patients receive conventional complete denture constructed from heat cure acrylic resin Receives: Other: conventional complete denture |
| CADCAM 3D printed denture | Active comparator | the patients receiveCADCAM 3D printed denture constructed by using printing machine Receives: Other: CADCAM 3D printed denture |
| CAD/CAM milled denture | Active comparator | the 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.
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)
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.
- First posted11 Mar 2021
- Study start20 Feb 2020
- Primary completion15 Nov 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Ahmed Ragheb, Kafrelsheikh University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biting Force and Chewing Efficiency of Conventional and CAD/CAM Complete Dentures: A Cross-over Study
- ClinicalTrials.gov ID
- NCT04793503
- Acronym / sponsor ID
- KD/07/21
- Conditions
- Biting, Chewing Problem
- Keywords
- complete denture, Biting force, chewing efficiency, CAD/CAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| conventional complete denture | Active comparator | Other: conventional complete denturethe patients receive conventional complete denture constructed from heat cure acrylic resin |
| CADCAM 3D printed denture | Active comparator | Other: CADCAM 3D printed denturethe patients receiveCADCAM 3D printed denture constructed by using printing machine |
| CAD/CAM milled denture | Active comparator | Other: CAD/CAM milled denturethe patients receiveCADCAM 3D printed denture constructed by using milling machine |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Abnormal jaw relation
- TMJ disorders
- Any systemic disease interfering with complete denture treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional complete denturethe complete denture constructed by packing technique | Other | conventional complete denture |
| CADCAM 3D printed dentureThe files from the laser-scan will be translated into stereolithography (STL) files and the CDs are virtually designed in ExoCad software | Other | CADCAM 3D printed denture |
| CAD/CAM milled dentureOnce the complete denture has been virtually designed in CAD software (ExoCad software) a preview will be sent for evaluation using 3D viewing software | Other | CAD/CAM milled denture |
Primary outcome
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.
- 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
1 secondary outcome
chewing efficiency
Time frame: 3 months after denture insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: Yes. mean and standard deviation for each outcome in each group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.