Effect of a Double Dose of Photobiomodulaton Therapy on Orthodonthic Pain Caused by Elastomeric Separators

NCT04532476 | Completed

• 1 other identifier: UHRijeka- laser
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

It has been reported that 90% of the patients experience pain during orthodontic treat-ment. The purpose of this study was to compare the effect of a double dose of photobio-modulation (PBM) therapy on pain perception in patients having fixed appliance treat-ment. Twenty-two patients were recruited to participate in this single-blinded, place-bo-controlled study. Four elastomeric separators were placed, mesially and distally to the upper first molar on each side. The right side of the upper jaw was treated with low-power diode laser, and the left side was a placebo, same treatment with laser switched off. Two doses of PBM therapy (660nm, 90mW) were delivered 24 hours apart. The par-ticipants filled out the questionnaire immediately after the placement of separators and before 1st laser treatment (TO), 12 hours (T1), 24 hours (T2), 2 days (T3) and 3 days after the 1st treatment (T4). At each evaluation period, the degree of pain was scored twice, one for each side.

Conditions

Pain Relief Caused by Placing Orthodontic Separators

Outcome Measures

Primary Outcomes (1)

• Assesment of pain

  The pain was assessed with a visual analogue scale (VAS), which is a 100-mm-long hori-zontal line where one end corresponds to "no pain" and the other end indicates "worst pain possible." The participants filled out the questionnaire immediately after the placement of separators (TO) and before 1st laser treatment, 12 hours (T1), 24hours (T2) and just after 2nd laser treatment, 2 days (T3) and 3 days after the 1st treatment (T4) (Table 1). At each evalua-tion period, the degree of pain was scored twice, one for each side. Each patient was re-quired to indicate whether he/she had taken any analgesics during the recorded period.

  3 days

Study Arms (2)

Laser treated side

EXPERIMENTAL

Group of 22 participants whose mucose around right maxillary permanent molar was treated with laser.

Device: Low level laser therapy

Placebo side

PLACEBO COMPARATOR

Placebo side was LEFT side.It was treated the same way as right with the difference that the laser was switched off, but with the maintained sound signal, implying laser was working, so participants were blinded to the allocation of the group, only the operator knew whether the side is laser treated or placebo.

Device: Low level laser therapy

Interventions

Low level laser therapy DEVICE

Diode laser (Laser HF, Hager-Werken GmbH \& Co., Duisburg, Germany) was applied to the RIGHT side. Laser was set at PDT mode (660nm) acupuncture therapy. The power of the laser was set at 90 mW in intervals of 80 seconds as recommended by the manufacturer. The laser was applied perpendicular in contact with the mucosa on 1 point of the buccal and 1 point on the palatal side of the first molar approximately on the middle part of the root, with the 10mm distance from the laser to the mucosa. Each point was treated in 3 intervals, 80s each, in total 240s on vestibular and 240s on the palatal side per tooth. The treated surface was 1cm2. The power of the laser was 90mW, wavelength 660n, beam area 1 cm2, irradiance per target 0.09 W/cm2, during 240 seconds of treatment interval per point- 21.6J/cm2 of energy was delivered. The same laser treatment was performed the next day, as the pain was noted to be highest within 24 hours after the placement of separators.

Also known as: LLLT

Laser treated side; Placebo side

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients aged between 12-19 years referred for orthodontic treatment, no previous orthodontic treatment, good general health , permanent dentition including second molars erupted, intact first maxillary permanent molars, good interproximal contacts on all maxillary first permanent molars, healty periodontal tissues ( gingival index=0, plaque index\<1, probing depths\<3mm, no peridontal attachment loss and no radiographic evidence of periodontal bone loss)

You may not qualify if:

• gingivitis/ periodontitis
• interproximal fillings
• missing teeth
• crowding or spacing in premolar or molar area
• severe systemic disease
• antibiotics or analgesics prescribed 15 days prior/during study

Sponsors & Collaborators

• University Hospital Rijeka: lead
• University of Zagreb: collaborator

Study Sites (1)

University Hospital Rijeka

Rijeka, 51000, Croatia

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Senka Mestrovic, DDS, PhD

  University of Zagreb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: It was determined in advance that the right side of the upper jaw was treated with laser, and the left side was placebo.Placebo side was treated the same way with the difference that the laser was switched off, but with the maintained sound signal, implying laser was working, so that partici-pants were blinded to the allocation of the group, only the operator knew whether the side is laser treated or placebo.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of dental medicine, orthodontist specialist

Model Details: This is a single -blinded, placebo controlled, split-mouth study. The design was split-mouth to eliminate all components related to differences among subjects.

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 31, 2020
• Study Start: March 20, 2020
• Primary Completion: June 20, 2020
• Study Completion: July 1, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)