EdentulousNCT01493232
Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
A study testing buccalized occlusion in people with Edentulous, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampling of 15 participant that will be signed informed consent and their latest teeth was extracted 3 month ago, will be selected. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous
- What is being tested?
- buccalized occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIran
- Study dates
- Oct 2011to May 2012
- 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
- edentulous patients
- at least 3 month ago the latest teeth was extracted
- ideal jaw relation
- signing the informed consent
Who cannot join
- uncontrolled systemic disease
- mentally problem
- dissatisfaction for keeping on the study
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan
Isfahan, Isfahan, 81745-319
Mohammad Javad Shirani, Under graduated Student, 00989356039479, javaad.sh_f@yahoo.com
Mohammad Javad Shirani, Under graduated Student
About this study
In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampling of 15 participant that will be signed informed consent and their latest teeth was extracted 3 month ago, will be selected. For each participant, it will be made 3 set of complete dentures that are variable in occlusion only. During the study, dissatisfied participants can leave it. Each set will be inserted for 1month in 5 participant randomly. The participants will be examined in two stages, after a day and after a week. At the end of month the questionaire will be filled out and the pressure under the mandibular denture base will be measured with the pressure sensors. Then the second and third denture will be inserted simultaneously.
- Conditions
- Edentulous
- Being tested
- buccalized occlusion
- Keywords
- Lingualized occlusion, Complete denture occlusion, Fully bilateral balanced occlusion, Patient satisfaction of complete denture
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccalized occlusionOther
Also called K06.9, Disorder of gingiva and edentulous alveolar ridge, unspecified
Making a set of complete denture with new Buccalized Occlusion that is different from current occlusion in my country. In this type just buccal casps of mandibular teeth will be connect to the central fossa of maxillary teeth and lingual casps have not contact.
| Study group | Role | What they receive |
|---|---|---|
| Denture, edentulous patient, treatment | Experimental | Dentures with different type of occlusion Receives: Other: buccalized occlusion |
| Denture, Edentulous patient, treatment | Experimental | Dentures with different type of occlusion Receives: Other: buccalized occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Satisfaction
method of measurement is Questionair
Measured: 1 year
Secondary outcomes (1)
Patients' Dissatisfaction
method of measurement Examination and Questionair
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdentulousStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Javad Shirani, Isfahan University of Medical Sciences
- Investigators
- Ramin Mosharraf, Prosthodontics Specialist, Study chair, Medical University of Isfahan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493232
- Sponsor's protocol ID
- 190052
- Other IDs
- IRCT201110097749N1
- Status last verified
- Dec 2011
- First submitted
- 12 Dec 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shirani M, Mosharraf R, Shirany M. Comparisons of patient satisfaction levels with complete dentures of different occlusions: a randomized clinical trial. J Prosthodont. 2014 Jun;23(4):259-66. doi: 10.1111/jopr.12101. Epub 2013 Oct 19.
PubMed 24138344
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
- ClinicalTrials.gov ID
- NCT01493232
- Acronym / sponsor ID
- 190052
- Conditions
- Edentulous
- Keywords
- Lingualized occlusion, Complete denture occlusion, Fully bilateral balanced occlusion, Patient satisfaction of complete denture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 15 Dec 2011 (estimated)
- 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.
In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampling of 15 participant that will be signed informed consent and their latest teeth was extracted 3 month ago, will be selected. For each participant, it will be made 3 set of complete dentures that are variable in occlusion only. During the study, dissatisfied participants can leave it. Each set will be inserted for 1month in 5 participant randomly. The participants will be examined in two stages, after a day and after a week. At the end of month the questionaire will be filled out and the pressure under the mandibular denture base will be measured with the pressure sensors. Then the second and third denture will be inserted simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denture, edentulous patient, treatment | Experimental | Other: buccalized occlusionDentures with different type of occlusion |
| Denture, Edentulous patient, treatment | Experimental | Other: buccalized occlusionDentures with different type of occlusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- edentulous patients
- at least 3 month ago the latest teeth was extracted
- ideal jaw relation
- signing the informed consent
Key exclusion criteria (3 listed)
- uncontrolled systemic disease
- mentally problem
- dissatisfaction for keeping on the study
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 |
|---|---|---|
| buccalized occlusionAlso: K06.9, Disorder of gingiva and edentulous alveolar ridge, unspecifiedMaking a set of complete denture with new Buccalized Occlusion that is different from current occlusion in my country. In this type just buccal casps of mandibular teeth will be connect to the central fossa of maxillary teeth and lingual casps have not contact. | Other | Denture, Edentulous patient, treatment, Denture, edentulous patient, treatment |
Primary outcome
Patients' Satisfaction
Time frame: 1 year
method of measurement is Questionair
1 secondary outcome
Patients' Dissatisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
- Derived from this study: PubMed 24138344Shirani M, Mosharraf R, Shirany M. Comparisons of patient satisfaction levels with complete dentures of different occlusions: a randomized clinical trial. J Prosthodont. 2014 Jun;23(4):259-66. doi: 10.1111/jopr.12101. Epub 2013 Oct 19.
- Department of Research and Technology, Medical University of Isfahan, IranLink provided by the sponsor.
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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.
Ramin Mosharraf, Prosthodontics Specialist study chair
Medical University of Isfahan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing buccalized occlusion in people with Edentulous, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Dec 2011. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Javad Shirani, Under graduated Student (00989356039479, javaad.sh_f@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Satisfaction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01493232, which also lists 1 linked publication.
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 20 Dec 2011.