The Influence of Communication After Placement of Orthodontic Fixed Appliances on Pain, Anxiety and Oral Health Quality of Life Among Malaysian Population
1 other identifier
interventional
250
1 country
1
Brief Summary
Assessing the influence of a telephone call or Whatsapp instant text message post bond up of fixed appliances on Pain Visual Analogue Scores, State-Trait Anxiety and Oral Health Quality of Life
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
1 active site
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
May 16, 2018
CompletedFirst Submitted
Initial submission to the registry
January 23, 2019
CompletedFirst Posted
Study publicly available on registry
January 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 25, 2019
January 1, 2019
12 months
January 23, 2019
January 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in pain (VAS)
measure daily change in pain post bonding of fixed appliances using a 10mm pain visual analogue scale. 0mm = no pain and 100mm = worst pain imaginable
every day for 1 week post bond up
Secondary Outcomes (1)
Change in Anxiety (STAI)
everyday for 1 week post bond up. It consists of 40 statements which require the participant to rate using a 4 point likert scale.Total scores can range between 40 to 160. Higher scores indicate increased anxiety .
Other Outcomes (1)
Change in Quality of life (OHIP-16)
everyday for 1 week post bond up
Study Arms (3)
Control
NO INTERVENTIONcontrol group with no intervention
intervention group receiving a Whatsapp instant text message with encouraging words after bond up of fixed appliances
Call
EXPERIMENTALintervention group receiving a phone cal with encouraging words after bond up of fixed appliances
Interventions
Eligibility Criteria
You may qualify if:
- New patients requiring fixed preadjusted appliances in both arches
- Age ≥ 16 years old
- Patients of Mongoloid ethnicity
- Patients with access to a cellular phone with Whatsapp instant messaging app
- Patients with access to internet services and email account for questionnaire completion
- Patients with partial bond up e.g delayed bond up of lower incisors or upper laterals
You may not qualify if:
- History of reported chronic use of analgesic medication
- History of chronic pain related pathology or disease
- History of previous fixed orthodontic intervention
- Patients that have recently had teeth extracted less than 2 weeks prior to bond up
- Patients requiring bond of both arches on separate days
- Syndromic patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, University Malaya
Kuala Lumpur, 50603, Malaysia
Related Publications (5)
Bartlett BW, Firestone AR, Vig KW, Beck FM, Marucha PT. The influence of a structured telephone call on orthodontic pain and anxiety. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):435-41. doi: 10.1016/j.ajodo.2004.06.033.
PMID: 16214624BACKGROUNDCozzani M, Ragazzini G, Delucchi A, Barreca C, Rinchuse DJ, Servetto R, Calevo MG, Piras V. Self-reported pain after orthodontic treatments: a randomized controlled study on the effects of two follow-up procedures. Eur J Orthod. 2016 Jun;38(3):266-71. doi: 10.1093/ejo/cjv032. Epub 2015 Jun 11.
PMID: 26070922BACKGROUNDKeith DJ, Rinchuse DJ, Kennedy M, Zullo T. Effect of text message follow-up on patient's self-reported level of pain and anxiety. Angle Orthod. 2013 Jul;83(4):605-10. doi: 10.2319/091812-742.1. Epub 2012 Dec 4.
PMID: 23210546BACKGROUNDMansor N, Saub R, Othman SA. Changes in the oral health-related quality of life 24 h following insertion of fixed orthodontic appliances. J Orthod Sci. 2012 Oct;1(4):98-102. doi: 10.4103/2278-0203.105880.
PMID: 24987635BACKGROUNDNgan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
PMID: 2750720BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
January 23, 2019
First Posted
January 25, 2019
Study Start
May 16, 2018
Primary Completion
May 1, 2019
Study Completion
December 1, 2019
Last Updated
January 25, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share