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

December 3, 2015 updated by: Romulo Rocha Regis, Universidade Federal do Ceara

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-160
        • Recruiting
        • Dental School of Federal University of Ceara
        • Contact:
        • Contact:
        • Principal Investigator:
          • Romulo R Regis, DDS, PhD
        • Sub-Investigator:
          • Wagner A Negreiros, DDS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simplified protocol

The application of a simplified denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps:

  1. Obtainment of maxillary and mandibular casts by using irreversible hydrocolloid in stainless steel stock trays for record bases fabrication.
  2. Adjustment of record bases according to vertical dimension and centric relation measurements, with no use of facebow transfer. Casts will be mounted in semi-adjustable articulator using standardized measures and artificial teeth will be selected.
  3. Trial dentures will be evaluated for esthetics and maxillomandibular relationship.
  4. Insertion of finished dentures.
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.
Other Names:
  • Fabrication of complete dentures
  • Complete denture fabrication technique
No Intervention: Traditional protocol

The importance of a second impression for denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps:

  1. Maxillary and mandibular casts obtained by using irreversible hydrocolloid in stainless steel stock trays for maxillary record base and mandibular custom tray fabrication.
  2. Mandibular second impression with border molding using compound and impression rubber in custom tray.
  3. Record bases adjustments without facebow transfer. Casts will be mounted in semi-adjustable articulator using standardized measures and artificial teeth will be selected.
  4. Trial dentures will be evaluated for esthetics and maxillomandibular relationship.
  5. Finished dentures insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health related quality of life
Time Frame: 6 months
This outcome will be assessed by means of the brazilian version of Oral Health Impact Profile for Edentulous Patients inventory
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with dentures (assessed by means of two specific questionaries)
Time Frame: 6 months
This outcome will be assessed by means of two specific questionaries
6 months
Denture quality (assessed by means of a clinical examination according to a specific form)
Time Frame: 3 months
This outcome will be assessed by means of a clinical examination according to a specific form
3 months
Masticatory performance (assessed by means of a colorimetric method based on an artificial test food)
Time Frame: 6 months
This outcome will be assessed by means of a colorimetric method based on an artificial test food
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Ceara

Collaborators

Fundação Cearense de Apoio ao Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Romulo R Regis, DDS, PhD, romuloregis@hotmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 136958818

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Edentulous Jaw

Clinical Trials on Denture fabrication technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe