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Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03391063
Collaborator
(none)
38
Enrollment
2
Arms
4.9
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: polyamide
  • Other: heat cured acrylic resin
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Feb 1, 2018
Anticipated Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: reinforced polyamide denture base

metal reinforced polyamide denture base

Other: polyamide
metal reinforced polyamide denture base material
Other Names:
  • nylon

    		•
    Active Comparator: conventional acrylic resin denture base

    conventional heat cured acrylic resin denture base

    Other: heat cured acrylic resin
    conventional heat cured acrylic resin denture base material

    Outcome Measures

    Primary Outcome Measures

    1. chewing efficiency assessed using sieving method [6 weeks]

      chewing efficiency of the mandibular complete denture

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female patient with age range (45-55) completely edentulous and in good medical condition.

    2. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.

    3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.

    4. Free from any tempro-mandibular joint disorder.

    5. The patients have good oral hygiene.

    6. The edentulous ridges should be covered by firm healthy mucosa.

    7. Healthy and co-operative patients.

    Exclusion Criteria:

    1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).

    2. Previous history of radiotherapy or chemotherapy.

    3. Any skeletal problem dictates surgical intervention.

    4. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.

    5. Patient with xerostomia or excessive salivation.

    6. No intraoral soft and hard tissue pathosis.

    7. Psychiatric problems.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahmoud Abdallah Abdelmottaleb, dentist, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03391063
    Other Study ID Numbers:
    • Reinforced complete denture
    First Posted:
    Jan 5, 2018
    Last Update Posted:
    Jan 5, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mouth, Edentulous

    Study Results

    No Results Posted as of Jan 5, 2018