NCT01493232

Brief Summary

In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampling of 15 participant that will be signed informed consent and their latest teeth was extracted 3 month ago, will be selected. For each participant, it will be made 3 set of complete dentures that are variable in occlusion only. During the study, dissatisfied participants can leave it. Each set will be inserted for 1month in 5 participant randomly. The participants will be examined in two stages, after a day and after a week. At the end of month the questionaire will be filled out and the pressure under the mandibular denture base will be measured with the pressure sensors. Then the second and third denture will be inserted simultaneously.

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

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

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

December 12, 2011

Last Update Submit

December 17, 2011

Conditions

Edentulous

Keywords

Lingualized occlusionComplete denture occlusionFully bilateral balanced occlusionPatient satisfaction of complete denture

Outcome Measures

Primary Outcomes (1)

  • Patients' Satisfaction

    method of measurement is Questionair

    1 year

Secondary Outcomes (1)

  • Patients' Dissatisfaction

    1 year

Study Arms (2)

Denture, edentulous patient, treatment

EXPERIMENTAL

Dentures with different type of occlusion

Other: buccalized occlusion

Denture, Edentulous patient, treatment

EXPERIMENTAL

Dentures with different type of occlusion

Other: buccalized occlusion

Interventions

buccalized occlusionOTHER

Making a set of complete denture with new Buccalized Occlusion that is different from current occlusion in my country. In this type just buccal casps of mandibular teeth will be connect to the central fossa of maxillary teeth and lingual casps have not contact.

Also known as: K06.9, Disorder of gingiva and edentulous alveolar ridge, unspecified
Denture, Edentulous patient, treatmentDenture, edentulous patient, treatment

Eligibility Criteria

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

You may qualify if:

  • edentulous patients
  • at least 3 month ago the latest teeth was extracted
  • ideal jaw relation
  • signing the informed consent

You may not qualify if:

  • uncontrolled systemic disease
  • mentally problem
  • dissatisfaction for keeping on the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan

Isfahan, Isfahan, 81745-319, Iran

RECRUITING

Related Publications (1)

  • Shirani M, Mosharraf R, Shirany M. Comparisons of patient satisfaction levels with complete dentures of different occlusions: a randomized clinical trial. J Prosthodont. 2014 Jun;23(4):259-66. doi: 10.1111/jopr.12101. Epub 2013 Oct 19.

    PMID: 24138344DERIVED

Related Links

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Ramin Mosharraf, Prosthodontics Specialist

    Medical University of Isfahan

    STUDY CHAIR

Central Study Contacts

Mohammad Javad Shirani, Under graduated Student

CONTACT

00989356039479javaad.sh_f@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohammad Javad Shirani, Isfahan University of Medical Sciences, Faculty of dentistry,Dnt.mui.ac.ir, Perincipal investigator, Dental student.

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 15, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations

IR(1)