Health Knowledge, Attitudes, PracticeNCT03184883
Comparative Study Between Acrylic and Flexible Dentures
A study testing single conventional denture and single flexible denture in people with Health Knowledge, Attitudes, Practice, run by Cairo University.
Trial summary
comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue and patient's satisfaction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- single conventional denture and single flexible denture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Dec 2017
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mandibular flat ridge
- Patient with opposing natural teeth or satisfactory fixed prostheses
- Angle class I Maxillimandibular relationship
- No intraoral soft and hard tissue pathosis
- Non smokers
- Patients with no previous denture experience
- Patients having last extraction at least 6 month before denture construction
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
Ahmed Fayad, lecturer contact
About this study
Official title: Comparative Study of Conventional Versus Flexible Mandibular Single Complete Denture
comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue and patient's satisfaction
Read the detailed description
comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue by keratinization index through PAP stain and patient's satisfaction through a questionnaire
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- single conventional denture, single flexible denture
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single conventional dentureProcedure or surgery
mandibular conventional denture with soft liner
single flexible dentureProcedure or surgery
mandibular flexible compete denture
| Study group | Role | What they receive |
|---|---|---|
| single conventional denture | Experimental | patients with mandibular edentulous arch by using acrylic resin denture with soft linner Receives: Procedure: single conventional denture |
| single flexible denture | Active comparator | patients with mandibular edentulous arch by using flexible lower denture Receives: Procedure: single flexible denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytological changes manifested as keratinization index
Objective Outcome: measuring the cytological changes manifested as keratinization index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Azer, Cairo University
- Investigators
- Essam Aziz, professor, Principal investigator, supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184883
- Sponsor's protocol ID
- evidence committee
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Conventional Versus Flexible Mandibular Single Complete Denture
- ClinicalTrials.gov ID
- NCT03184883
- Acronym / sponsor ID
- evidence committee
- Conditions
- Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 14 Jun 2017 (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.
comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue and patient's satisfaction
Detailed description
comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue by keratinization index through PAP stain and patient's satisfaction through a questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single conventional denture | Experimental | Procedure: single conventional denturepatients with mandibular edentulous arch by using acrylic resin denture with soft linner |
| single flexible denture | Active comparator | Procedure: single flexible denturepatients with mandibular edentulous arch by using flexible lower denture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Mandibular flat ridge
- Patient with opposing natural teeth or satisfactory fixed prostheses
- Angle class I Maxillimandibular relationship
- No intraoral soft and hard tissue pathosis
- Non smokers
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 |
|---|---|---|
| single conventional denturemandibular conventional denture with soft liner | Procedure or surgery | single conventional denture |
| single flexible denturemandibular flexible compete denture | Procedure or surgery | single flexible denture |
Primary outcome
Cytological changes manifested as keratinization index
Time frame: 6 months
Objective Outcome: measuring the cytological changes manifested as keratinization index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Ahmed Fayad, lecturer contact
Essam Aziz, professor principal investigator
supervisor
Questions about this trial
What is this clinical trial studying?
A study testing single conventional denture and single flexible denture in people with Health Knowledge, Attitudes, Practice, run by Cairo University.
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 7 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Marianne Azer, Bachelor (01227243531, marianne.fouad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytological changes manifested as keratinization index (time frame: 6 months). 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 21 Jul 2017.