Measuring Quality of Life of Poly-amide Complete Dentures

Metal-reinforced Flexible Poly-amide Complete Denture Versus Heat-cured Poly-methyl Methacrylate in Terms of Oral Health Related Quality of Life; Randomized Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03234803

Enrollment

Registered

2017-07-31

Start date

2018-01-01

Completion date

2018-05-01

Last updated

2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Denture, Complete

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.

Interventions

OTHERpoly-amide

new denture base material

OTHERpoly-methyl methacrylate

gold standard for denture base materials

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
oral health related quality of life	one month	OHIP-49 questionnaire

Contacts

Primary ContactAmr Nasr, DDS

denamr12@gmail.com01285247060

Backup ContactMaha El Kerdawy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026