Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges

Edentulous Jaw Clinical Trial

Official title:

Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02339194
• Other study ID #: 136958818
• Status: Recruiting
• Phase: Phase 3
• First received: January 12, 2015
• Last updated: December 3, 2015
• Start date: January 2014
• Est. completion date: July 2016

Study information

• Verified date: December 2015
• Source: Universidade Federal do Ceara
• Contact: Samara M Sales, DDS
• Phone: 8596523217
• Email: samarah_sales[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

BACKGROUND: The literature has shown that simplified methods for complete denture fabrication can be as effective as the traditional techniques, but with less expenditure of time and resources, without prejudice to the patients. However, the effectiveness of these simplified methods for patients with more complex medical conditions haven't been deeply explored.

OBJECTIVES: To evaluate the effectiveness of a proposed simplified method for complete dentures fabrication for patients with severely resorbed mandibular alveolar bones.

METHOD: edentulous patients requesting treatment with bimaxillary complete dentures in a university clinic will be rehabilitated following a simplified technical proposal, being divided randomly into two groups according to the mandibular arch molding technique. In group A, a single impression with alginate through pre-fabricated trays will be performed, while patients allocated in group B will receive a second molding with a more complex technique. After 3 and 6 months, besides important clinical parameters, it will be investigated aspects related to patient's perceptions about the success of treatment. The study will be conducted with a minimum of 30 participants per group, and comparisons between the two groups will be made by means of tests suitable for distribution of data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• complete edentulism for at least one year;

• desire to receive a pair of new conventional complete dentures

• mental receptiveness;

• good understanding of spoken Portuguese

Exclusion Criteria:

• disorders of the masticatory system;

• pathological changes of residual ridges;

• debilitating systemic diseases.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Edentulous Jaw
• Edentulous Mouth
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Procedure:
• Denture fabrication technique
Both arm groups are composed by patients present severely resorbed mandibular alveolar bones who will receive complete dentures fabricated by means of a simpler techinique previously proved to be effective. Although for the "traditional protocol" group a second more complex impression step will be performed in order to evaluate if the simpler approach for this anatomical condition could be safely applied.

Locations

Country	Name	City	State
Brazil	Dental School of Federal University of Ceara	Fortaleza	Ceara

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Ceara	Fundação Cearense de Apoio ao Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Cunha TR, Della Vecchia MP, Regis RR, Ribeiro AB, Muglia VA, Mestriner W Jr, de Souza RF. A randomised trial on simplified and conventional methods for complete denture fabrication: masticatory performance and ability. J Dent. 2013 Feb;41(2):133-42. doi: 10.1016/j.jdent.2012.09.008. Epub 2012 Sep 19. — View Citation

Kawai Y, Murakami H, Shariati B, Klemetti E, Blomfield JV, Billette L, Lund JP, Feine JS. Do traditional techniques produce better conventional complete dentures than simplified techniques? J Dent. 2005 Sep;33(8):659-68. — View Citation

Kawai Y, Murakami H, Takanashi Y, Lund JP, Feine JS. Efficient resource use in simplified complete denture fabrication. J Prosthodont. 2010 Oct;19(7):512-6. doi: 10.1111/j.1532-849X.2010.00628.x. Epub 2010 Aug 16. — View Citation

Nuñez MC, Silva DC, Barcelos BA, Leles CR. Patient satisfaction and oral health-related quality of life after treatment with traditional and simplified protocols for complete denture construction. Gerodontology. 2015 Dec;32(4):247-53. doi: 10.1111/ger.12078. Epub 2013 Oct 21. — View Citation

Omar R, Al-Tarakemah Y, Akbar J, Al-Awadhi S, Behbehani Y, Lamontagne P. Influence of procedural variations during the laboratory phase of complete denture fabrication on patient satisfaction and denture quality. J Dent. 2013 Oct;41(10):852-60. doi: 10.1016/j.jdent.2013.07.013. Epub 2013 Aug 1. — View Citation

Regis RR, Cunha TR, Della Vecchia MP, Ribeiro AB, Silva-Lovato CH, de Souza RF. A randomised trial of a simplified method for complete denture fabrication: patient perception and quality. J Oral Rehabil. 2013 Jul;40(7):535-45. doi: 10.1111/joor.12063. Epub 2013 May 12. — View Citation

Vecchia MP, Regis RR, Cunha TR, de Andrade IM, da Matta JC, de Souza RF. A randomized trial on simplified and conventional methods for complete denture fabrication: cost analysis. J Prosthodont. 2014 Apr;23(3):182-91. doi: 10.1111/jopr.12090. Epub 2013 Jul 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral health related quality of life	This outcome will be assessed by means of the brazilian version of Oral Health Impact Profile for Edentulous Patients inventory	6 months	No
Secondary	Satisfaction with dentures (assessed by means of two specific questionaries)	This outcome will be assessed by means of two specific questionaries	6 months	No
Secondary	Denture quality (assessed by means of a clinical examination according to a specific form)	This outcome will be assessed by means of a clinical examination according to a specific form	3 months	No
Secondary	Masticatory performance (assessed by means of a colorimetric method based on an artificial test food)	This outcome will be assessed by means of a colorimetric method based on an artificial test food	6 months	No