Pain and Activity Levels After Orthodontic Separators

NCT05615688 | Completed

• 1 other identifier: 55656
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to evaluate the reported pain intensity following placement of Orthodontic separators on healthy volunteers aged 15-49 in relation to their recorded physical activity level. Hypothesis 1: The investigators hypothesize that participants with higher daily step counts and physical activity levels will report significantly less pain intensity from orthodontic separators than their less active peers following separator placement. Null hypothesis is that participants with higher daily step counts will report the same pain intensity from orthodontic separators than their less active peers following separator placement The secondary aim is to describe the course of pain, at 24 hr intervals, over the next seven days following separator placement. Hypothesis 2: The investigators hypothesize that more physically active participants will report ratings of zero pain intensity faster (sooner) than their less active peers throughout the one week study. Secondary null hypothesis is that more physically active participants will report ratings of zero pain intensity at the same rate as their less active peers throughout the one week study.

Conditions

Dental Malocclusion

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Subjects will be given an activity monitor to wear full time following the placement of the orthodontic spacers. They will report their level of pain to on a recurrent Pain Intensity questionnaire (using a Visual Analog Scale in REDCap) at 2-4 hrs after placement, and again at 24 hour intervals for the next 7 days following separator placement. The left of the digital Visual Analog Scale will be labeled "no pain" and the right will be labeled "worst pain imaginable". REDCap assigns a value of 0 on the left side of the scale and increased to100 on the right of the scale.

  7 days

Secondary Outcomes (1)

• Change in Proportion of patients reporting ZERO Pain over time

  7 days

Study Arms (1)

Orthodontic Separators Placed

EXPERIMENTAL

Elastomeric separators will be placed on the mesial and distal of the lower first permanent molars for a total of four separators per subject.

Procedure: Pain Intensity following Placement of Orthodontic Separators

Interventions

Pain Intensity following Placement of Orthodontic Separators PROCEDURE

Elastomeric separators will be placed on the mesial and distal of lower first permanent molars for a total of four separators per subject. Subjects will wear receive an activity monitor prior to placement of elastic separators and instructed to wear it 24/7 unless showering or swimming. Subjects will complete a recurrent Pain Scale Questionnaire 2-4 hrs after placement of elastics and every 24 hrs from day 2- 7.

Orthodontic Separators Placed

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Student, resident, or staff at the University of Kentucky
• Aged 15-49 at time of enrollment in the study
• Erupted permanent first and second molars with interproximal contacts
• Presence of antagonist teeth in the opposite arch with no open bite
• Voluntary participation in study
• Access to a smartphone, tablet, or computer
• Valid email address

You may not qualify if:

• Any chronic pain condition (examples include trigeminal neuralgia, migraines, fibromyalgia, arthritis, neuropathies)
• Current use of pain medication (analgesics, opioids, nerve pain medications) for any condition
• Clinically evident interproximal decay in the site where separators will be placed
• Missing teeth, variations in tooth anatomy, existing space, and or restorations that would keep separators from being placed or retained
• If you do not have access to a computer, smartphone, or tablet with internet access

Sponsors & Collaborators

• Lina Sharab: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (10)

• Bergius M, Berggren U, Kiliaridis S. Experience of pain during an orthodontic procedure. Eur J Oral Sci. 2002 Apr;110(2):92-8. doi: 10.1034/j.1600-0722.2002.11193.x.

  PMID: 12013568 BACKGROUND

• Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.

  PMID: 9844209 BACKGROUND

• Abu Alhaija ES, Aldaikki A, Al-Omairi MK, Al-Khateeb SN. The relationship between personality traits, pain perception and attitude toward orthodontic treatment. Angle Orthod. 2010 Nov;80(6):1141-9. doi: 10.2319/012710-59.1.

  PMID: 20677967 BACKGROUND

• Beck VJ, Farella M, Chandler NP, Kieser JA, Thomson WM. Factors associated with pain induced by orthodontic separators. J Oral Rehabil. 2014 Apr;41(4):282-8. doi: 10.1111/joor.12144. Epub 2014 Feb 1.

  PMID: 24483937 BACKGROUND

• Campos LA, Santos-Pinto A, Maroco J, Campos JADB. Pain perception in orthodontic patients: A model considering psychosocial and behavioural aspects. Orthod Craniofac Res. 2019 Aug;22(3):213-221. doi: 10.1111/ocr.12315. Epub 2019 May 15.

  PMID: 31021044 BACKGROUND

• Rakhshan H, Rakhshan V. Pain and discomfort perceived during the initial stage of active fixed orthodontic treatment. Saudi Dent J. 2015 Apr;27(2):81-7. doi: 10.1016/j.sdentj.2014.11.002. Epub 2015 Jan 27.

  PMID: 26082574 BACKGROUND

• Sandhu SS, Leckie G. Orthodontic pain trajectories in adolescents: Between-subject and within-subject variability in pain perception. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):491-500.e4. doi: 10.1016/j.ajodo.2015.10.020.

  PMID: 27021453 BACKGROUND

• Sandhu SS, Sandhu J. Orthodontic pain: an interaction between age and sex in early and middle adolescence. Angle Orthod. 2013 Nov;83(6):966-72. doi: 10.2319/030113-174.1. Epub 2013 May 24.

  PMID: 23705940 BACKGROUND

• Ngan 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: 2750720 BACKGROUND

• Bondemark L, Fredriksson K, Ilros S. Separation effect and perception of pain and discomfort from two types of orthodontic separators. World J Orthod. 2004 Summer;5(2):172-6.

  PMID: 15615136 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Lina Sharab, DDS, MS, MSc

  Assistant Professor, Orthodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Elastomeric separators will be placed on the mesial and distal of lower first permanent molars for a total of four separators per subject. Activity monitors will be provided and participants instructed to wear 24/7 unless showering or swimming to measure and collect level of physical activity Baseline data will be collected via questionnaires that include: Medical History, Demographics, and Perceived Stress Scale. Subjects will also complete a Recurrent Questionnaire at 2-4 hrs post placement and every evening for days 2-7 to report Pain Intensity using a Visual Analog Scale

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: November 14, 2022
• Study Start: July 14, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)