Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture
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)
1 other identifier
interventional
38
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJanuary 5, 2018
January 1, 2018
3 months
December 29, 2017
January 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
chewing efficiency assessed using sieving method
chewing efficiency of the mandibular complete denture
6 weeks
Study Arms (2)
reinforced polyamide denture base
EXPERIMENTALmetal reinforced polyamide denture base
conventional acrylic resin denture base
ACTIVE COMPARATORconventional heat cured acrylic resin denture base
Interventions
metal reinforced polyamide denture base material
conventional heat cured acrylic resin denture base material
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (1)
Vojdani M, Giti R. Polyamide as a Denture Base Material: A Literature Review. J Dent (Shiraz). 2015 Mar;16(1 Suppl):1-9.
PMID: 26106628BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Amal Kaddah
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dentist
Study Record Dates
First Submitted
December 29, 2017
First Posted
January 5, 2018
Study Start
February 1, 2018
Primary Completion
May 1, 2018
Study Completion
July 1, 2018
Last Updated
January 5, 2018
Record last verified: 2018-01