NCT03385746

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 28, 2017

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

December 21, 2017

Last Update Submit

December 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Retention assessed by digital forcemeter

    Retention of mandibular denture

    6 weeks

Study Arms (2)

polyamide

EXPERIMENTAL

metal reinforced polyamide denture base material

Other: polyamide

heat cured acrylic resin

ACTIVE COMPARATOR

conventional heat cured acrylic resin denture base

Other: heat cured acrylic resin

Interventions

metal reinforced polyamide denture base material

Also known as: Nylon
polyamide

conventional heat cured acrylic resin denture base material

heat cured acrylic resin

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Neuromuscular disorder and orofacial disease.
  • Tempromandibular joint and muscle pain
  • xerostomia or excessive salivation.
  • Limited mouth opening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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
  • Soygun K, Bolayir G, Boztug A. Mechanical and thermal properties of polyamide versus reinforced PMMA denture base materials. J Adv Prosthodont. 2013 May;5(2):153-60. doi: 10.4047/jap.2013.5.2.153. Epub 2013 May 30.

    PMID: 23755341BACKGROUND

MeSH Terms

Conditions

Anodontia of Permanent Dentition

Interventions

Nylons

Intervention Hierarchy (Ancestors)

PlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

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 21, 2017

First Posted

December 28, 2017

Study Start

February 1, 2018

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

December 28, 2017

Record last verified: 2017-12