NCT00959530

Brief Summary

The purpose of this study is to find the difference between patient satisfaction, masticatory performance and cost between two occlusal schemes for complete denture prosthodontics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

August 13, 2009

Last Update Submit

March 27, 2017

Conditions

Jaw, Edentulous

Keywords

complete denturespatient satisfactiontreatment cost

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction on 100mm visual analogue scale

    6month

Secondary Outcomes (1)

  • treatment cost

    6month

Study Arms (2)

lingualized

EXPERIMENTAL

complete denture fabricated by lingualized occlusion scheme

Procedure: lingualized occlusion

Full Bilaterally Balanced Articulation

PLACEBO COMPARATOR

complete denture fabricated by Full Bilaterally Balanced Articulation scheme

Procedure: Full Bilaterally Balanced Articulation

Interventions

lingualized occlusionPROCEDURE

occlusal surface arranged by lingualized occlusion

Also known as: e-ha artificial teeth, shofu porcelain teeth
lingualized
Full Bilaterally Balanced ArticulationPROCEDURE

occlusal surface arranged by Full Bilaterally Balanced Articulation

Also known as: Shofu Ace Posterior
Full Bilaterally Balanced Articulation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • edentulous both maxilla and mandible, asking for new denture fabrication

You may not qualify if:

  • psychiatric problem
  • those who have difficulty answering the questionnaire
  • oral cancer
  • radiation experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nihon University Hospital

Matsudo, Chiba, 2718587, Japan

Location

Related Publications (5)

  • Heydecke G, Vogeler M, Wolkewitz M, Turp JC, Strub JR. Simplified versus comprehensive fabrication of complete dentures: patient ratings of denture satisfaction from a randomized crossover trial. Quintessence Int. 2008 Feb;39(2):107-16.

    PMID: 18560649BACKGROUND

  • Sutton AF, Worthington HV, McCord JF. RCT comparing posterior occlusal forms for complete dentures. J Dent Res. 2007 Jul;86(7):651-5. doi: 10.1177/154405910708600713.

    PMID: 17586713BACKGROUND

  • Sutton AF, McCord JF. A randomized clinical trial comparing anatomic, lingualized, and zero-degree posterior occlusal forms for complete dentures. J Prosthet Dent. 2007 May;97(5):292-8. doi: 10.1016/j.prosdent.2007.03.003.

    PMID: 17547948BACKGROUND

  • Kimoto S, Gunji A, Yamakawa A, Ajiro H, Kanno K, Shinomiya M, Kawai Y, Kawara M, Kobayashi K. Prospective clinical trial comparing lingualized occlusion to bilateral balanced occlusion in complete dentures: a pilot study. Int J Prosthodont. 2006 Jan-Feb;19(1):103-9.

    PMID: 16479769BACKGROUND

  • Matsumaru Y. Influence of mandibular residual ridge resorption on objective masticatory measures of lingualized and fully bilateral balanced denture articulation. J Prosthodont Res. 2010 Jul;54(3):112-8. doi: 10.1016/j.jpor.2009.11.008. Epub 2010 Jan 19.

    PMID: 20089469DERIVED

MeSH Terms

Conditions

Jaw, EdentulousPatient Satisfaction

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Yasuhiko Kawai, DDS MMedSc

    Nihon University

    PRINCIPAL INVESTIGATOR

  • Yuichi Matsumaru, DDS

    Nihon University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

November 1, 2007

Primary Completion

September 1, 2009

Study Completion

December 1, 2011

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

JP(1)