NCT02108470

Brief Summary

The aim of this study is to determine whether by incorporating an Oral Health-Related Quality of Life (OHRQoL) measure in dental practice will improve patient-dentist communication and enhance patient's satisfaction. The objectives of this study are: (i) To determine the measurement equivalence of Computer Touch Screen Assessment (CTSA) and Paper Based Assessment (PBA) of the Oral Health Impact Profile (OHIP-14). (ii) To evaluate and compare how useful a standardized OHRQoL assessment improves patient-dentist communication with regards to number of relevant OHRQoL issues addressed and percentage of most frequently items discussed between the intervention and control groups, assess the patient's active participation between the intervention and control groups and enhances patient's satisfaction between the intervention and control groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

March 31, 2014

Last Update Submit

February 4, 2020

Conditions

Oral HealthQuality of Life

Keywords

Oral Health Related Quality of Life (OHRQoL)Oral Health Impact Profile (OHIP)Dentist-Patient Relationspatients' participation.patients' satisfaction with the consultation.

Outcome Measures

Primary Outcomes (3)

  • The number or percentage of relevant OHRQoL issues addressed

    For each consultation, score will be given based on the number of problems discussed. The composite score can range from 0-14; where 0 no issue discussed and 14 all issues discussed.

    1 day ( after dental consultation)

  • The patient's participation between the intervention and control groups

    Patient's participation will be measured by determining the length of time patient speaks to the dentist. Estimated duration will be made based on the audiotape.

    1 day ( after dental consultation)

  • 9-item Consultation Satisfaction Questionnaire (CSQ) will be used in this study.

    The CSQ-9 looks at 4 different areas of satisfaction; general satisfaction (2 questions), professional care (4 questions), depth of relationship (2 questions) and perceived time (1 questions).

    1 day ( after dental consultation)

Study Arms (2)

Dental consultation without OHQoL assessment

NO INTERVENTION

Dentist performs consultation in the traditional method

Dental consultation using OHIP

EXPERIMENTAL

Dental consultation using OHIP incorporating OHRQoL issues.

Other: Dental consultation using OHIP

Interventions

Dental consultation using OHIPOTHER

The S-OHIP\[M\] measure assesses the impact of one's oral health condition on QoL, contributing to 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Responses of each item are made on a Likert scale and coded as: 1 = never, 2 =hardly ever, 3= occasionally, 4= fairly often, and 5= very often.

Also known as: Oral Health Impact Profile (OHIP-14)
Dental consultation using OHIP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 and older with presenting complaint of oral pain are eligible to participate in this study.

You may not qualify if:

  • Patients who are illiterate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goverment Dental Clinics

Shah Alam, Selangor, 40000, Malaysia

Location

Study Officials

  • Roslan Saub, PhD

    University of Malaya

    PRINCIPAL INVESTIGATOR

  • Colman McGrath, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • Zainab Shamdol, Master

    Ministry of Health, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 9, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

MY(1)