NCT02339194

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

2.5 years

First QC Date

January 12, 2015

Last Update Submit

December 3, 2015

Conditions

Edentulous MouthEdentulous Jaw

Keywords

complete denturequality of lifepatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Satisfaction with dentures (assessed by means of two specific questionaries)

    6 months

  • Denture quality (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)

    6 months

Study Arms (2)

Simplified protocol

EXPERIMENTAL

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

Traditional protocol

NO INTERVENTION

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.

Interventions

Denture fabrication techniquePROCEDURE

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.

Also known as: Fabrication of complete dentures, Complete denture fabrication technique
Simplified protocol

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • complete edentulism for at least one year;
  • desire to receive a pair of new conventional complete dentures
  • mental receptiveness;
  • good understanding of spoken Portuguese

You may not qualify if:

  • disorders of the masticatory system;
  • pathological changes of residual ridges;
  • debilitating systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental School of Federal University of Ceara

Fortaleza, Ceará, 60430-160, Brazil

RECRUITING

Related Publications (9)

  • 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.

    PMID: 16139697BACKGROUND

  • 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.

    PMID: 20723019BACKGROUND

  • 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.

    PMID: 23000525BACKGROUND

  • 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.

    PMID: 23663152BACKGROUND

  • 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.

    PMID: 23890072BACKGROUND

  • 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.

    PMID: 23911602BACKGROUND

  • 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.

    PMID: 24147575BACKGROUND

  • 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.

    PMID: 32437857DERIVED

  • 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.

    PMID: 32380132DERIVED

MeSH Terms

Conditions

Mouth, EdentulousJaw, EdentulousPatient Satisfaction

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesJaw DiseasesMusculoskeletal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Romulo R Regis, DDS, PhD

    romuloregis@hotmail.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samara M Sales, DDS

CONTACT

8596523217samarah_sales@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Rômulo Rocha Regis

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 15, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

BR(1)