Complete EdentulismNCT03253510
Measuring Biting Force of Poly-amide Complete Dentures
A study testing Poly-amide and Poly-methyl methacrylate in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.
Trial summary
Randomized clinical trial to compare between biting force of mandibular complete denture constructed from two different materials; metal reinforced polyamide and conventional PMMA,The null hypothesis of the study that there will not be a difference between biting force of the complete denture constructed from metal… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Poly-amide and Poly-methyl methacrylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2017to 1 May 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
- Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
- Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- Free from any tempro-mandibular disease.
- Good oral hygiene
Who cannot join
- Neuromuscular disorder and orofacial disease.
- Tempromandibular joint and muscle pain
- xerostomia or excessive salivation.
- Limited mouth opening
- Abnormal tongue behavior and/or size.
- Intraoral soft and hard tissue pathosis
Trial locations and contacts
1 site in 1 country.
nadia abbas contact
Egypt1 site
Hadeer Hadi
Cairo, 002
hadeer abdelhadi abdelhameed, master, 01158834401, hadeerhadi1990@gmail.com
About this study
Official title: Comparison Between Biting Force of Heat Cured Poly Methylmethacrylate and Metal Reinforced Polyamide for Mandibular Complete Denture
Randomized clinical trial to compare between biting force of mandibular complete denture constructed from two different materials; metal reinforced polyamide and conventional PMMA,The null hypothesis of the study that there will not be a difference between biting force of the complete denture constructed from metal reinforced polyamide and PMMA
Read the detailed description
Polyamide resins used in dentistry exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response. Although flexural strength, modulus of elasticity and rigidity of nylon (polyamide) denture base materials are relatively low, they demonstrate great impact strength, toughness, and resistance to fracture. It was suggested that by adding glass fibers to polyamides, their stiffness and other mechanical properties could be increased. The flexural properties of nylon denture base materials has promoted their usage only in conditions like unyielding undercuts, pronounced tuberosities, tori and bulging alveolar ridges. In 2013 Wadachi etal compared rigidity of polyamide and PMMA when used as a denture base material and concluded that; the modulus of elasticity of polyamide was very low in comparison to PMMA and was lower than ISO standard, and so they recommended that polyamide to be used as a denture base material it should be reinforced with metal frame
- Conditions
- Complete Edentulism
- Being tested
- Poly-amide, Poly-methyl methacrylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-amideOther
Also called Nylon
New denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response
Poly-methyl methacrylateOther
Also called PMMA
Gold standard denture base material
| Study group | Role | What they receive |
|---|---|---|
| Poly-amide | Experimental | new thermoplastic material used as a denture base, that has excellent ethetics and flexibility Receives: Other: Poly-amide |
| poly-methyl methacrylate | Active comparator | Polymethylmethacrylate is one of the most widely used denture base material, because of its good biocompatibility, reliability and dimensional stability Receives: Other: Poly-methyl methacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biting force
Bite force will be measured for both types of complete denture after one month of denture insertion . The recorded force during maximal clenching was obtained with I-load sensor placed between pairs of opposing teeth at one side and wood tongue depressor at the other side. The meter and depressor were located at the area of premolar/molar where there is more number of occlusal contacts with strong determinant of muscle action and subsequent great bite force.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study startSep 2017 (estimated)
- Primary completion1 Mar 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies 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
- Model description
- Participants are assigned to two more groups in parallel for the duration of the study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Hadi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253510
- Sponsor's protocol ID
- Poly-amide complete dentures
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Biting Force of Heat Cured Poly Methylmethacrylate and Metal Reinforced Polyamide for Mandibular Complete Denture
- ClinicalTrials.gov ID
- NCT03253510
- Acronym / sponsor ID
- Poly-amide complete dentures
- Conditions
- Complete Edentulism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 18 Aug 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.
Randomized clinical trial to compare between biting force of mandibular complete denture constructed from two different materials; metal reinforced polyamide and conventional PMMA,The null hypothesis of the study that there will not be a difference between biting force of the complete denture constructed from metal reinforced polyamide and PMMA
Detailed description
Polyamide resins used in dentistry exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response. Although flexural strength, modulus of elasticity and rigidity of nylon (polyamide) denture base materials are relatively low, they demonstrate great impact strength, toughness, and resistance to fracture. It was suggested that by adding glass fibers to polyamides, their stiffness and other mechanical properties could be increased. The flexural properties of nylon denture base materials has promoted their usage only in conditions like unyielding undercuts, pronounced tuberosities, tori and bulging alveolar ridges. In 2013 Wadachi etal compared rigidity of polyamide and PMMA when used as a denture base material and concluded that; the modulus of elasticity of polyamide was very low in comparison to PMMA and was lower than ISO standard, and so they recommended that polyamide to be used as a denture base material it should be reinforced with metal frame
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to two more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Poly-amide | Experimental | Other: Poly-amidenew thermoplastic material used as a denture base, that has excellent ethetics and flexibility |
| poly-methyl methacrylate | Active comparator | Other: Poly-methyl methacrylatePolymethylmethacrylate is one of the most widely used denture base material, because of its good biocompatibility, reliability and dimensional stability |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
- Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
- Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- Free from any tempro-mandibular disease.
- Good oral hygiene
Key exclusion criteria (6 listed)
- Neuromuscular disorder and orofacial disease.
- Tempromandibular joint and muscle pain
- xerostomia or excessive salivation.
- Limited mouth opening
- Abnormal tongue behavior and/or size.
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 |
|---|---|---|
| Poly-amideAlso: NylonNew denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response | Other | Poly-amide |
| Poly-methyl methacrylateAlso: PMMAGold standard denture base material | Other | poly-methyl methacrylate |
Primary outcome
Biting force
Time frame: One month
Bite force will be measured for both types of complete denture after one month of denture insertion . The recorded force during maximal clenching was obtained with I-load sensor placed between pairs of opposing teeth at one side and wood tongue depressor at the other side. The meter and depressor were located at the area of premolar/molar where there is more number of occlusal contacts with strong determinant of muscle action and subsequent great bite force.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- 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.
nadia abbas contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-amide and Poly-methyl methacrylate in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 6 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 18 Aug 2017. 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 Egypt. 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 Hadeer Abdel hadi Abd elhameed, master (01158834401, hadeerhadi1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biting force (time frame: One month). 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 18 Aug 2017.