Measuring Quality of Life of Poly-amide Complete Dentures

Denture, Complete Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03234803
• Other study ID #: polyamide_complete dentures
• Status: Not yet recruiting
• Phase: N/A
• First received: July 27, 2017
• Last updated: July 27, 2017
• Start date: January 1, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: Amr Nasr, DDS
• Phone: 01285247060
• Email: denamr12[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: May 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Denture, Complete

Intervention

Other:
• poly-amide
new denture base material
• poly-methyl methacrylate
gold standard for denture base materials

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

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