Biting Force and Chewing Efficiency of Complete Dentures.
Primary Purpose
Biting, Chewing Problem
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional complete denture
CADCAM 3D printed denture
CAD/CAM milled denture
Sponsored by
About this trial
This is an interventional treatment trial for Biting focused on measuring complete denture, Biting force, chewing efficiency, CAD/CAM
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Abnormal jaw relation
- TMJ disorders
- Any systemic disease interfering with complete denture treatment
Sites / Locations
- Faculty of Dentistry , Kafr El Shiekh University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
conventional complete denture
CADCAM 3D printed denture
CAD/CAM milled denture
Arm Description
the patients receive conventional complete denture constructed from heat cure acrylic resin
the patients receiveCADCAM 3D printed denture constructed by using printing machine
the patients receiveCADCAM 3D printed denture constructed by using milling machine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04793503
First Posted
January 24, 2021
Last Updated
August 31, 2021
Sponsor
Kafrelsheikh University
1. Study Identification
Unique Protocol Identification Number
NCT04793503
Brief Title
Biting Force and Chewing Efficiency of Complete Dentures.
Official Title
Biting Force and Chewing Efficiency of Conventional and CAD/CAM Complete Dentures: A Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biting, Chewing Problem
Keywords
complete denture, Biting force, chewing efficiency, CAD/CAM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
the patient doesn't recognise the type of complete denture that he use
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional complete denture
Arm Type
Active Comparator
Arm Description
the patients receive conventional complete denture constructed from heat cure acrylic resin
Arm Title
CADCAM 3D printed denture
Arm Type
Active Comparator
Arm Description
the patients receiveCADCAM 3D printed denture constructed by using printing machine
Arm Title
CAD/CAM milled denture
Arm Type
Active Comparator
Arm Description
the patients receiveCADCAM 3D printed denture constructed by using milling machine
Intervention Type
Other
Intervention Name(s)
conventional complete denture
Intervention Description
the complete denture constructed by packing technique
Intervention Type
Other
Intervention Name(s)
CADCAM 3D printed denture
Intervention Description
The files from the laser-scan will be translated into stereolithography (STL) files and the CDs are virtually designed in ExoCad software
Intervention Type
Other
Intervention Name(s)
CAD/CAM milled denture
Intervention Description
Once the complete denture has been virtually designed in CAD software (ExoCad software) a preview will be sent for evaluation using 3D viewing software
Primary Outcome Measure Information:
Title
biting force
Description
- 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
Time Frame
Readings will be performed baseline 1 week after denture insertion then 1 month after denture insertion then 3 months after denture insertion.
Secondary Outcome Measure Information:
Title
chewing efficiency
Description
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.
Time Frame
3 months after denture insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Abnormal jaw relation
TMJ disorders
Any systemic disease interfering with complete denture treatment
Facility Information:
Facility Name
Faculty of Dentistry , Kafr El Shiekh University
City
Kafr Ash Shaykh
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
mean and standard deviation for each outcome in each group
Learn more about this trial
Biting Force and Chewing Efficiency of Complete Dentures.
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