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

Primary Purpose

Edentulous Mouth, Edentulous Jaw

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Denture fabrication technique
Sponsored by
Universidade Federal do Ceara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Edentulous Mouth focused on measuring complete denture, quality of life, patient satisfaction

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dental School of Federal University of CearaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Simplified protocol

Traditional protocol

Arm Description

The application of a simplified denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps: Obtainment of maxillary and mandibular casts by using irreversible hydrocolloid in stainless steel stock trays for record bases fabrication. 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. Trial dentures will be evaluated for esthetics and maxillomandibular relationship. Insertion of finished dentures.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Satisfaction with dentures (assessed by means of two specific questionaries)
This outcome will be assessed by means of two specific questionaries
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
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

Full Information

First Posted
January 12, 2015
Last Updated
December 3, 2015
Sponsor
Universidade Federal do Ceara
Collaborators
Fundação Cearense de Apoio ao Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02339194
Brief Title
Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges
Official Title
Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Ceara
Collaborators
Fundação Cearense de Apoio ao Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth, Edentulous Jaw
Keywords
complete denture, quality of life, patient satisfaction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simplified protocol
Arm Type
Experimental
Arm Description
The application of a simplified denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps: Obtainment of maxillary and mandibular casts by using irreversible hydrocolloid in stainless steel stock trays for record bases fabrication. 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. Trial dentures will be evaluated for esthetics and maxillomandibular relationship. Insertion of finished dentures.
Arm Title
Traditional protocol
Arm Type
No Intervention
Arm Description
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: Maxillary and mandibular casts obtained by using irreversible hydrocolloid in stainless steel stock trays for maxillary record base and mandibular custom tray fabrication. Mandibular second impression with border molding using compound and impression rubber in custom tray. Record bases adjustments without facebow transfer. Casts will be mounted in semi-adjustable articulator using standardized measures and artificial teeth will be selected. Trial dentures will be evaluated for esthetics and maxillomandibular relationship. Finished dentures insertion.
Intervention Type
Procedure
Intervention Name(s)
Denture fabrication technique
Other Intervention Name(s)
Fabrication of complete dentures, Complete denture fabrication technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oral health related quality of life
Description
This outcome will be assessed by means of the brazilian version of Oral Health Impact Profile for Edentulous Patients inventory
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Satisfaction with dentures (assessed by means of two specific questionaries)
Description
This outcome will be assessed by means of two specific questionaries
Time Frame
6 months
Title
Denture quality (assessed by means of a clinical examination according to a specific form)
Description
This outcome will be assessed by means of a clinical examination according to a specific form
Time Frame
3 months
Title
Masticatory performance (assessed by means of a colorimetric method based on an artificial test food)
Description
This outcome will be assessed by means of a colorimetric method based on an artificial test food
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samara M Sales, DDS
Phone
8596523217
Email
samarah_sales@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romulo R Regis, DDS, PhD
Organizational Affiliation
romuloregis@hotmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental School of Federal University of Ceara
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-160
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samara M Sales, DDS
Phone
8596523217
Email
samarah_sales@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ivo Albuquerque, DDS
Phone
8599220937
Email
ivo_albuquerque@hotmail.com
First Name & Middle Initial & Last Name & Degree
Romulo R Regis, DDS, PhD
First Name & Middle Initial & Last Name & Degree
Wagner A Negreiros, DDS, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16139697
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. doi: 10.1016/j.jdent.2005.01.005.
Results Reference
background
PubMed Identifier
20723019
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.
Results Reference
background
PubMed Identifier
23000525
Citation
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.
Results Reference
background
PubMed Identifier
23663152
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.
Results Reference
background
PubMed Identifier
23890072
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.
Results Reference
background
PubMed Identifier
23911602
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.
Results Reference
background
PubMed Identifier
24147575
Citation
Nunez 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.
Results Reference
background
PubMed Identifier
32437857
Citation
Albuquerque IS, Freitas-Pontes KM, de Souza RF, Negreiros WA, Ramos MB, Peixoto RF, Regis RR. Is a two-step impression mandatory for complete denture fabrication on the severely resorbed mandible? A randomized trial on mastication, patient satisfaction and adjustments. J Dent. 2020 Aug;99:103357. doi: 10.1016/j.jdent.2020.103357. Epub 2020 May 8.
Results Reference
derived
PubMed Identifier
32380132
Citation
Albuquerque IS, Regis RR, de Souza RF, Gurgel KF, Silva PG, Pinto-Fiamengui LMS, Freitas-Pontes KM. Is a two-step impression mandatory for complete denture fabrication on the severely resorbed mandible? A randomized trial on patient perception and denture quality. J Dent. 2020 Jul;98:103356. doi: 10.1016/j.jdent.2020.103356. Epub 2020 May 5.
Results Reference
derived

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

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