NCT03234803

Brief Summary

Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base material because of its several advantages as; good esthetics, adequate strength, easy repair and simple processing techniques. As any material it has some problems as polymerization shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was introduced into dentistry to be used as a denture base material in order to solve these problems. Polyamide denture base materials have some superior properties than PMMA as; High impact \& flexural strength, excellent esthetics and less release of residual monomers4. Although being an advantage from the point of patient satisfaction, flexural property considered to be a contraindication for a denture base material. The invistigators' trial is done in order to improve rigidity of a polyamide material as well as to improve oral health related quality of life in comparison to heat cured polymethyl methacrylate.

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
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

July 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

July 27, 2017

Last Update Submit

July 27, 2017

Conditions

Denture, Complete

Outcome Measures

Primary Outcomes (1)

  • oral health related quality of life

    OHIP-49 questionnaire

    one month

Study Arms (2)

poly-amide

EXPERIMENTAL

poly-amide is a thermoplastic material recently introduced to be used as a complete denture material, that provide excellent aesthetics and flexibility.

Other: poly-amide

poly-methyl methacrylate

ACTIVE COMPARATOR

poly-methyl methacrylate has been commonly used as a material for constructing complete dentures and proved to have high success rate and considered to be gold standard.

Other: poly-methyl methacrylate

Interventions

poly-amideOTHER

new denture base material

Also known as: Nylon
poly-amide
poly-methyl methacrylateOTHER

gold standard for denture base materials

poly-methyl methacrylate

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- i. Male or female patient with age range (45-55) and in good medical condition ii. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient inter-arch distance.
  • iii. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  • iv. Free from any tempro-mandibular joint disorder. v. The patients have good oral hygiene.

You may not qualify if:

  • \- i. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
  • ii. Patient with xerostomia or excessive salivation. iii. Patient with abnormal tongue behavior and/or size. iv. No intraoral soft and hard tissue pathosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ali IL, Yunus N, Abu-Hassan MI. Hardness, flexural strength, and flexural modulus comparisons of three differently cured denture base systems. J Prosthodont. 2008 Oct;17(7):545-9. doi: 10.1111/j.1532-849X.2008.00357.x. Epub 2008 Aug 26.

    PMID: 18761582BACKGROUND

  • Wadachi J, Sato M, Igarashi Y. Evaluation of the rigidity of dentures made of injection-molded materials. Dent Mater J. 2013;32(3):508-11. doi: 10.4012/dmj.2013-061.

    PMID: 23719015BACKGROUND

  • Schwindling FS, Rammelsberg P, Stober T. Effect of chemical disinfection on the surface roughness of hard denture base materials: a systematic literature review. Int J Prosthodont. 2014 May-Jun;27(3):215-25. doi: 10.11607/ijp.3759.

    PMID: 24905261BACKGROUND

MeSH Terms

Interventions

NylonsPolymethyl Methacrylate

Intervention Hierarchy (Ancestors)

PlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureMethylmethacrylatesPolymethacrylic AcidsAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAcrylic ResinsResins, Synthetic

Central Study Contacts

Amr Nasr, DDS

CONTACT

01285247060denamr12@gmail.com

Maha El Kerdawy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal resident at removable prosthodontic department

Study Record Dates

First Submitted

July 27, 2017

First Posted

July 31, 2017

Study Start

January 1, 2018

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

July 31, 2017

Record last verified: 2017-07