Mouth, EdentulousNCT03391063
Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture
A study testing polyamide and heat cured acrylic resin in people with Mouth, Edentulous, run by Cairo University.
Trial summary
the trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- polyamide and heat cured acrylic resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 1 Jul 2018
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient with age range (45-55) completely edentulous and in good medical condition.
- All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
- Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- Free from any tempro-mandibular joint disorder.
- The patients have good oral hygiene.
- The edentulous ridges should be covered by firm healthy mucosa.
- Healthy and co-operative patients.
Who cannot join
- Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
- Previous history of radiotherapy or chemotherapy.
- Any skeletal problem dictates surgical intervention.
- Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
- Patient with xerostomia or excessive salivation.
- No intraoral soft and hard tissue pathosis.
- Psychiatric problems.
Trial locations and contacts
No sites are listed yet.
Amal Kaddah contact
About this study
Official title: Evaluation Of Chewing Efficiency Of Metal-Reinforced PolyAmide Denture Base In Comparison To Conventional Heat Cured Acrylic Resin Denture Base For Mandibular Complete Denture (A Randomized Clinical Trial)
the trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases
- Conditions
- Mouth, Edentulous
- Being tested
- polyamide, heat cured acrylic resin
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyamideOther
Also called nylon
metal reinforced polyamide denture base material
heat cured acrylic resinOther
conventional heat cured acrylic resin denture base material
| Study group | Role | What they receive |
|---|---|---|
| reinforced polyamide denture base | Experimental | metal reinforced polyamide denture base Receives: Other: polyamide |
| conventional acrylic resin denture base | Active comparator | conventional heat cured acrylic resin denture base Receives: Other: heat cured acrylic resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
chewing efficiency assessed using sieving method
chewing efficiency of the mandibular complete denture
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Feb 2018 (estimated)
- Primary completion1 May 2018 (estimated)
- Study completion1 Jul 2018 (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 Mouth, EdentulousStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdallah Abdelmottaleb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391063
- Sponsor's protocol ID
- Reinforced complete denture
- Status last verified
- Jan 2018
- First submitted
- 29 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vojdani M, Giti R. Polyamide as a Denture Base Material: A Literature Review. J Dent (Shiraz). 2015 Mar;16(1 Suppl):1-9.
PubMed 26106628
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Chewing Efficiency Of Metal-Reinforced PolyAmide Denture Base In Comparison To Conventional Heat Cured Acrylic Resin Denture Base For Mandibular Complete Denture (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03391063
- Acronym / sponsor ID
- Reinforced complete denture
- Conditions
- Mouth, Edentulous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 5 Jan 2018 (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 trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reinforced polyamide denture base | Experimental | Other: polyamidemetal reinforced polyamide denture base |
| conventional acrylic resin denture base | Active comparator | Other: heat cured acrylic resinconventional heat cured acrylic resin denture base |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient with age range (45-55) completely edentulous and in good medical condition.
- All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
- Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- Free from any tempro-mandibular joint disorder.
- The patients have good oral hygiene.
Key exclusion criteria (7 listed)
- Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
- Previous history of radiotherapy or chemotherapy.
- Any skeletal problem dictates surgical intervention.
- Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
- Patient with xerostomia or excessive salivation.
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 |
|---|---|---|
| polyamideAlso: nylonmetal reinforced polyamide denture base material | Other | reinforced polyamide denture base |
| heat cured acrylic resinconventional heat cured acrylic resin denture base material | Other | conventional acrylic resin denture base |
Primary outcome
chewing efficiency assessed using sieving method
Time frame: 6 weeks
chewing efficiency of the mandibular complete denture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Background: PubMed 26106628Vojdani M, Giti R. Polyamide as a Denture Base Material: A Literature Review. J Dent (Shiraz). 2015 Mar;16(1 Suppl):1-9.
- Individual participant dataSharing planned: Undecided
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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.
Amal Kaddah contact
Questions about this trial
What is this clinical trial studying?
A study testing polyamide and heat cured acrylic resin in people with Mouth, Edentulous, 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 7 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 5 Jan 2018. 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 mahmoud abdallah abdelomttaleb, B.D.S (01016344118, m.abdalla2022@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chewing efficiency assessed using sieving method (time frame: 6 weeks). 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 NCT03391063, 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 5 Jan 2018.