Effect of Low-Level Laser Therapy on Spontaneous and Chewing Pain Associated With Orthodontic Elastomeric Separator Placement

NCT07651774 | Completed

• 1 other identifier: FUCD-Ortho- 2603
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the efficacy of LLLT at a wavelength of 635 nm on:

• Spontaneous pain between laser and placebo group with the placement of orthodontic elastomeric separators.
• Chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators Study design: Randomized Controlled Trial (split-mouth study). Setting: Department of Orthodontics, Foundation University College of Dentistry \& Hospital (FUCD\&H). Duration of study: Six months after approval of synopsis. Sample size: 80 By using WHO calculator the sample size is 80, 40 sample in each group. Sampling method: Purposive sampling. Data Collection Procedure:
• Permission has been taken and already submitted from the Ethical Committee of Foundation University College of Dentistry \& Hospital (FUCD\&H), for the study.
• An informed written consent of the patient will be obtained on consent form. (Annexure-A)
• Patients reporting to orthodontic department of FUCD\&H for orthodontic treatment fulfilling the inclusion criteria in our sample will be selected after history, clinical examination \& radiographic evaluation.
• Four elastomeric separators will be placed by an orthodontic resident, using dental floss, for the first permanent molars (distal and mesial), either on maxillary or mandibular arches with a split mouth study design.
• Allocation of quadrant will be randomized by simple randomization method in which experimental side will be randomly allocated to the patient and opposite side of the same patient will act as control.
• Diode laser of 635 nm, in direct contact with a power output of 100mW in pulsed wave mode will be used on the experimental side. The laser will be applied bucally and lingually on two points: mucosa adjacent to the mesial and distal contact points of the permanent first molar, for 20 s each.
• The vertical level of laser application will be approximately at the center of the root with the fiber tip of the laser placed nearly perpendicular in close contact with the gingival tissue.
• For the placebo quadrant, a similar procedure will be carried out but with no laser irradiation, without the patient's knowledge.
• After 24 hours, patients will return to the clinic and receive the laser irradiation on the same quadrant.
• After placing the elastomeric separators, patients will be given a pain questionnaire for 7 days, gathering data on the age, gender, and the involved jaw (maxilla or mandible). Patients will be instructed to record spontaneous pain as well as pain on chewing, and mark their level of pain on a VAS. They will be asked to mark the pain level for both jaws immediately at hour 0 (before laser irradiation), after 6, 24, and 30 h, and on the days 3, 4, 5, 6, and 7.
• All the procedural observation will be carried out by the trainee researcher himself, under the supervision of his Supervisor.
• Patient will submit the VAS to the trainee researcher on day 8.

Conditions

Pain; Chewing Function; Low Level Laser Therapy; Visual Analog Scale; Orthodontics

Keywords

Elastomeric separators; Orthodontics; Orthodontic Pain; Chewing Pain; Spontaneous pain

Outcome Measures

Primary Outcomes (1)

• Spontaneous and chewing pain between laser and placebo group with the placement of orthodontic elastomeric separators with Visual Analogue Scale (VAS)

  • After placing the elastomeric separators, patients will be given a pain questionnaire for 7 days, gathering data on the age, gender, and the involved jaw (maxilla or mandible). Patients will be instructed to record spontaneous pain as well as pain on chewing, and mark their level of pain on a VAS. They will be asked to mark the pain level for both sides immediately at hour 0 (before laser irradiation), after 6, 24, and 30 hours, and on the days 3, 4, 5, 6, and 7.

  pain level for both sides immediately at hour 0 (before laser irradiation), after 6, 24, and 30 hours , and on the days 3, 4, 5, 6, and 7.

Study Arms (2)

Low Level Laser Therapy

EXPERIMENTAL

Effect of LLLT on pain associated with separator placement

Device: Low Level Laser Therapy

Control Group

PLACEBO COMPARATOR

No Therapy provided

Device: Control

Interventions

Low Level Laser Therapy DEVICE

• Diode laser of 635 nm, in direct contact with a power output of 100mW in pulsed wave mode will be used on the experimental side. The laser will be applied bucally and lingually on two points: mucosa adjacent to the mesial and distal contact points of the permanent first molar, for 20 s each

Low Level Laser Therapy

Control DEVICE

No therapy given

Control Group

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy and complete dentition including permanent second molars. • Good oral hygiene (absence of generalized calculus deposits assessed clinically).

You may not qualify if:

• Patients on pain killers or anti-inflammatory medication.
• Spacing between molars and premolars.
• History of diabetes mellitus, epilepsy or any other medical condition.
• Ongoing periodontal disease.
• Past history of orthodontic treatment.

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (1)

• 1. Shi Q, Yang S, Jia F, Xu J. Does low level laser therapy relieve the pain caused by the placement of the orthodontic separators? a meta-analysis. Head Face Med. 2015;11(1):1-9. 2. Ortega SM, Gonçalves ML, da Silva T, Horliana AC, Motta LJ, Altavista OM, Olivan SR, Dos Santos AE, Martimbianco AL, Mesquita-Ferrari RA, Fernandes KP. Evaluation of the use of photobiomodulation following the placement of elastomeric separators: protocol for a randomized controlled clinical trial. J of Med. 2019;98(43). 3. Marini I, Bartolucci ML, Bortolotti F, Innocenti G, Gatto MR, Bonetti GA. The effect of diode superpulsed low-level laser therapy on experimental orthodontic pain caused by elastomeric separators: a randomized controlled clinical trial. Lasers Med Sci. 2015;30(1):35-41. 4. Kim WT, Bayome M, Park JB, Park JH, Baek SH, Kook YA. Effect of frequent laser irradiation on orthodontic pain: a single-blind randomized clinical trial. Angle Orthod. 2013;83(4):611-6. 5. Tamgonda S, Reddy YM, Raj KP, Reddy R, Dharamdeep G. Effect of Low Level Laser Therapy: A Novel Approach to Diminish Pain Associated With Elastomeric Separators. Annals of International Med and Dent Research. 2019;5(6):38.

  BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: June 16, 2026
• Study Start: June 2, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2024
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)