NCT02951507

Brief Summary

Comparison of new design of extra coronal castable precision attachment (OT unilateral attachment) and conventional partial denture in patient satisfaction and biting force.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 29, 2016

Last Update Submit

October 31, 2016

Conditions

Patient Acceptance of Health Care

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    OHIP-14 questionnaire

    12 months

Secondary Outcomes (1)

  • Biting force

    12 months

Study Arms (2)

Conventional partial denture

ACTIVE COMPARATOR

Intervention will be O T unilateral attachment

Other: O T unilateral attachment

Conventional removal partial denture

ACTIVE COMPARATOR

Intervention will be new design of extra coronal attachment( O T unilateral attachment)

Other: New design of extracoronal attachment system

Interventions

O T unilateral attachmentOTHER

O T unilateral attachment system

Conventional partial denture
New design of extracoronal attachment systemOTHER

O T unilateral attachment

Conventional removal partial denture

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with unilateral mandibular distal extension area
  • Normal crown/root ratio of last premolar
  • co-operative patients

You may not qualify if:

  • completely edentulous patient
  • few remaining teeth
  • patients exposed to radiotherapy and chemotherapy
  • patients with maxillary or mandibular defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 29, 2016

First Posted

November 1, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Last Updated

November 1, 2016

Record last verified: 2016-10