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Measuring Quality of Life of Poly-amide Complete Dentures

NCT ID: NCT03234803

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Denture, Complete

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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poly-amide

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

Group Type EXPERIMENTAL

poly-amide

Intervention Type OTHER

new denture base material

poly-methyl methacrylate

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.

Group Type ACTIVE_COMPARATOR

poly-methyl methacrylate

Intervention Type OTHER

gold standard for denture base materials

Interventions

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poly-amide

new denture base material

Intervention Type OTHER

poly-methyl methacrylate

gold standard for denture base materials

Intervention Type OTHER

Other Intervention Names

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Nylon

Eligibility Criteria

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Inclusion Criteria

\- 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.

Exclusion Criteria

\- 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Magdy Ibrahim

Internal resident at removable prosthodontic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amr Nasr, DDS

Role: CONTACT

Phone: 01285247060

Email: [email protected]

Maha El Kerdawy

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 18761582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23719015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24905261 (View on PubMed)

Other Identifiers

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polyamide_complete dentures

Identifier Type: -

Identifier Source: org_study_id