Back to resultsEvaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture
Primary Purpose
Mouth, Edentulous
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polyamide
heat cured acrylic resin
Sponsored by
About this trial
This is an interventional treatment trial for Mouth, Edentulous
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
reinforced polyamide denture base
conventional acrylic resin denture base
Arm Description
metal reinforced polyamide denture base
conventional heat cured acrylic resin denture base
Outcomes
Primary Outcome Measures
chewing efficiency assessed using sieving method
chewing efficiency of the mandibular complete denture
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03391063
Brief Title
Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth, Edentulous
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
reinforced polyamide denture base
Arm Type
Experimental
Arm Description
metal reinforced polyamide denture base
Arm Title
conventional acrylic resin denture base
Arm Type
Active Comparator
Arm Description
conventional heat cured acrylic resin denture base
Intervention Type
Other
Intervention Name(s)
polyamide
Other Intervention Name(s)
nylon
Intervention Description
metal reinforced polyamide denture base material
Intervention Type
Other
Intervention Name(s)
heat cured acrylic resin
Intervention Description
conventional heat cured acrylic resin denture base material
Primary Outcome Measure Information:
Title
chewing efficiency assessed using sieving method
Description
chewing efficiency of the mandibular complete denture
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mahmoud abdallah abdelomttaleb, B.D.S
Phone
01016344118
Email
m.abdalla2022@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amal Kaddah
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26106628
Citation
Vojdani M, Giti R. Polyamide as a Denture Base Material: A Literature Review. J Dent (Shiraz). 2015 Mar;16(1 Suppl):1-9.
Results Reference
background
Learn more about this trial
Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture
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