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Edentulous MouthPhase 3NCT02339194

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

A Phase 3 study testing Denture fabrication technique in people with Edentulous Mouth and Edentulous Jaw, run by Universidade Federal do Ceara at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Edentulous Mouth, Edentulous Jaw
What is being tested?
Denture fabrication technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteBrazil
Study dates
Jan 2014to Jul 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Samara M Sales, DDS contact

8596523217

samarah_sales@hotmail.com

Brazil1 site, 1 recruiting

  • Dental School of Federal University of Ceara

    Fortaleza, Ceará, 60430-160

    Samara M Sales, DDS, 8596523217, samarah_sales@hotmail.com

    Ivo Albuquerque, DDS, 8599220937, ivo_albuquerque@hotmail.com

    Recruiting

Other trials in Brazil

About this study

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.

Being tested
Denture fabrication technique
Keywords
complete denture, quality of life, patient satisfaction
Medical subject headings
Mouth, Edentulous, Jaw, Edentulous, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Denture fabrication techniqueProcedure or surgery

    Also called Fabrication of complete dentures, Complete 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.

Study groups in NCT02339194
Study groupRoleWhat they receive
Simplified protocolExperimentalThe 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.
Receives: Procedure: Denture fabrication technique
Traditional protocolNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (3)

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

    This outcome will be assessed by means of two specific questionaries

    Measured: 6 months

  2. 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

    Measured: 3 months

  3. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02339194
Sponsor's protocol ID
136958818
Status last verified
Dec 2015
First submitted
12 Jan 2015
Last updated
4 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16139697

  • 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.

    PubMed 20723019

  • 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.

    PubMed 23000525

  • 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.

    PubMed 23663152

  • 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.

    PubMed 23890072

  • 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.

    PubMed 23911602

  • 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.

    PubMed 24147575

  • 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.

    PubMed 32437857

  • 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.

    PubMed 32380132

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Denture fabrication technique in people with Edentulous Mouth and Edentulous Jaw, run by Universidade Federal do Ceara at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Samara M Sales, DDS (8596523217, samarah_sales@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral health related quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02339194, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.

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