NCT03159520

Brief Summary

To compare the analgesic property of acupressure with NSAIDs (Ibuprofen) in controlling pain following orthodontic treatment. This will be achieved by assessing the effectiveness of acupressure in controlling pain and discomfort by measuring the degree of pain relief after bonding of brackets to teeth and placement of initial archwire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

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

First Submitted

Initial submission to the registry

May 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

May 14, 2017

Last Update Submit

February 21, 2019

Conditions

Orthodontic Appliance Complication

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain experience

    Visual analogue scale

    7 days

Secondary Outcomes (3)

  • Impact of pain on sleep

    7 days

  • Impact of pain on eating

    7 days

  • Rescue medication

    7 days

Study Arms (2)

Advice on acupressure

ACTIVE COMPARATOR

Advice sheet on use of acupressure for post orthodontic pain

Behavioral: Advice sheet

Advice on analgesics

ACTIVE COMPARATOR

Advice sheet on use of NSAID analgesics for post orthodontic pain

Behavioral: Advice sheet

Interventions

Advice sheetBEHAVIORAL

Advice on management of post orthodontic pain

Advice on acupressureAdvice on analgesics

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • aged 12-25
  • malocclusion requiring treatment
  • scheduled to begin orthodontic treatment
  • requires fixed orthodontic braces on upper and lower teeth.

You may not qualify if:

  • previous orthodontic treatment
  • current use of analgesics
  • contraindications to the use of NSAIDs
  • previous acupressure experience
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dundee Dental Hospital

Dundee, DD1 4HR, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David R Bearn, BDS

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Not possible to mask due to nature of intervention except for outcome assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised parallel clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2017

First Posted

May 18, 2017

Study Start

June 27, 2017

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)