Simplified vs. Conventional Methods for Complete Denture Fabrication

NCT01230320 | Completed

• 3 other identifiers: FORP-PT-0012010.1.971.58.02010/09381-9
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: The fabrication of complete dentures traditionally involves a series of complex technical procedures. Those procedures include two impressions for each jaw, the registration of the relationship between the upper teeth and the patient's head and usually two appointments for tooth try-in. However, recent studies have questioned the real need for such complex procedures. Simplified methods could have similar results if compared with conventional ones, and dentures would be delivered faster and with lower costs. OBJECTIVES: This study aims to compare the effectiveness complete dentures fabricated with a simplified or conventional method. METHODS: Eighty edentulous patients who requested treatment by maxillary and mandibular complete denture in a public dental clinic inside the University of Sao Paulo - Ribeirão Preto Dental School will be randomly divided into two groups. Group S will receive new dentures fabricated by a simplified method, whereas Group C will received new dentures according to a conventional method. Participants will complete a questionnaire for denture satisfaction and the oral health-related quality of life, 3 and 6 months after treatment. At the same time, a specialist in dental prostheses will evaluate the quality of new dentures.

Conditions

Edentulous Mouth; Edentulous Jaw

Keywords

Cost estimates; Complete Denture; Dental Economics; Dental Impression Technique; Denture Retention; Edentulous; Edentulism; Oral Health-Related Quality of Life; Patient Acceptance of Health Care; Patient Satisfaction; Quality of Health Care; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Oral health-related quality of life

  To be assessed by means of the Brazilian version of the OHIP-EDENT.

  6 months

Secondary Outcomes (4)

• Denture satisfaction

  6 months

• Denture quality

  3 months

• Post-insertion adjustments

  14 days

• Treatment costs

  6 months

Study Arms (2)

Simplified (S) technique

EXPERIMENTAL

Complete dentures fabricated according to a simplified technique, divided into the following four sessions: 1. Maxillary and mandibular casts will be obtained from irreversible hydrocolloid impressions made in stock trays. 2. Record bases will be adjusted according to vertical dimension and centric relation measurements, without facebow transfer. Casts will be mounted in a semi-adjustable articulator using standardized measures and artificial teeth will be selected. 3. Trial dentures will be evaluated for esthetics and maxillomandibular relationships. 4. Insertion of finished dentures.

Procedure: Denture fabrication technique

Conventional (C) technique

ACTIVE COMPARATOR

Complete dentures fabricated according to a conventional technique: 1. Initial impression and the obtainment of custom trays; 2. Final impression with border molding using compound; 3. Facebow transfer; 4. Determination of maxillomandibular relationship; 5. Try-in of anterior teeth; 6. Try-in of posterior teeth; 7. Insertion of finished dentures.

Procedure: Denture fabrication technique

Interventions

Denture fabrication technique PROCEDURE

Sequence of procedures involved with the fabrication of conventional complete dentures. Examples of common procedures are: 1. the reproduction of denture-bearing tissues by means of impression techniques and casts; 2. the registration of maxillo-mandibular relations; 3. try-in of artificial teeth and carved denture bases.

Also known as: - Fabrication of complete dentures;, - Complete denture fabrication technique.

Conventional (C) technique; Simplified (S) technique

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous for at least 1 year
• Patients requesting new maxillary and mandibular complete dentures
• Mental receptiveness
• Good understanding of spoken Portuguese

You may not qualify if:

• Debilitating systemic diseases
• Pathologic changes of residual edentulous ridges
• Dysfunctional disorders of the masticatory system

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Ribeirão Preto Dental School

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Links

• Institutional page of the Ribeirão Preto Dental School (research site)
• Principal Investigator´s CV

MeSH Terms

Conditions

Mouth, Edentulous; Jaw, Edentulous; Patient Acceptance of Health Care; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Jaw Diseases; Musculoskeletal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Raphael F de Souza, DDS, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2014
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

BR (1)