MasticationNCT03966703
Masticatory Efficiency in Implant-fixed Complete Dentures Compared to the Conventional Dentures
A study testing mixing analysing test in people with Mastication, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
Purpose of this study is to compare the masticatory efficiency 'All on four' to 'Complete dentures on a class I ridge' with a color mixing analyzing test. Ten Patients with fixed complete dentures on implants and other ten patients with complete denture on a class I ridge (Atwood) had chewed a bicolor chewing gum… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mastication
- What is being tested?
- mixing analysing test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jul 2017to 1 Feb 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- good general health, good intraoral conditions, and dentures in satisfactory conditions over edentulous high ridge Atwood's Class I. The minimum time of complete denture use ranged from 3 to 6 months. no temporomandibular dysfunction
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Masticatory Efficiency in Implant-fixed Complete Dentures Compared to the Conventional Dentures: a Randomized Clinical Trial by Color Mixing Analysis Test.
Purpose of this study is to compare the masticatory efficiency 'All on four' to 'Complete dentures on a class I ridge' with a color mixing analyzing test. Ten Patients with fixed complete dentures on implants and other ten patients with complete denture on a class I ridge (Atwood) had chewed a bicolor chewing gum (Hubba Bubba ®) for different number of cycles(5-10-15-20). The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency
- Conditions
- Mastication
- Being tested
- mixing analysing test
- Keywords
- complete denture, implant-fixed denture, masticatory efficiency, mixing ability test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixing analysing testBehavioural
Also called gum weight, hubba bubba
The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency
| Study group | Role | What they receive |
|---|---|---|
| conventional denture | Experimental | 10 patients chewed a 2 color gum for 5 cycles 10, 15 and 20.each sample is retrieved weighted and scanned Receives: Behavioral: mixing analysing test |
| implant fixed denture | Experimental | 10 patients chewed a 2 color gum for 5 cycles 10, 15 and 20.each sample is retrieved weighted and scanned Receives: Behavioral: mixing analysing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
color analysis mixing test
a two color chewing gum is chewed for a specific number of cycles, gum is scanned and color mixing is analysed by a software called View Gum
Measured: from 5 up to 20 second
Secondary outcomes (1)
weight reduction
gum is weighted before each chewing cycle than dried and weighted after chewing.weight reduction is the secondary outcome for mastication efficiency analyzing
Measured: from 5 up to 20 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jul 2017
- Primary completion1 Sep 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MasticationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 10 patients from each group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elie Jasser, St Joseph University, Beirut, Lebanon
- Investigators
- Elie Jasser, DSD, Principal investigator, Master student in aesthetic and prosthetic dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966703
- Sponsor's protocol ID
- USJ -2017-65
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masticatory Efficiency in Implant-fixed Complete Dentures Compared to the Conventional Dentures: a Randomized Clinical Trial by Color Mixing Analysis Test.
- ClinicalTrials.gov ID
- NCT03966703
- Acronym / sponsor ID
- USJ -2017-65
- Conditions
- Mastication
- Keywords
- complete denture, implant-fixed denture, masticatory efficiency, mixing ability test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 29 May 2019 (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.
Purpose of this study is to compare the masticatory efficiency 'All on four' to 'Complete dentures on a class I ridge' with a color mixing analyzing test. Ten Patients with fixed complete dentures on implants and other ten patients with complete denture on a class I ridge (Atwood) had chewed a bicolor chewing gum (Hubba Bubba ®) for different number of cycles(5-10-15-20). The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 10 patients from each group
| Arm | Type | Receives |
|---|---|---|
| conventional denture | Experimental | Behavioral: mixing analysing test10 patients chewed a 2 color gum for 5 cycles 10, 15 and 20.each sample is retrieved weighted and scanned |
| implant fixed denture | Experimental | Behavioral: mixing analysing test10 patients chewed a 2 color gum for 5 cycles 10, 15 and 20.each sample is retrieved weighted and scanned |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- good general health, good intraoral conditions, and dentures in satisfactory conditions over edentulous high ridge Atwood's Class I. The minimum time of complete denture use ranged from 3 to 6 months. no temporomandibular dysfunction
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| mixing analysing testAlso: gum weight, hubba bubbaThe chewed gum is retrieved scanned and weighted to quantify masticatory efficiency | Behavioural | conventional denture, implant fixed denture |
Primary outcome
color analysis mixing test
Time frame: from 5 up to 20 second
a two color chewing gum is chewed for a specific number of cycles, gum is scanned and color mixing is analysed by a software called View Gum
1 secondary outcome
weight reduction
Time frame: from 5 up to 20 second
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 29 May 2019.
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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.
Elie Jasser, DSD principal investigator
Master student in aesthetic and prosthetic dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mixing analysing test in people with Mastication, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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 1 inclusion and 1 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 29 May 2019. 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 Lebanon. 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?
color analysis mixing test (time frame: from 5 up to 20 second). 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 29 May 2019.