NCT05550168

Brief Summary

The objective of this trial is to investigate the effect of low-level laser therapy (LLLT) on orthodontic tooth movement during maxillary molar distalization over 12-week observation period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 15, 2022

Last Update Submit

September 21, 2022

Conditions

Keywords

Accelerated orthodontic tooth movementBiostimulationMolar distalizationHumans

Outcome Measures

Primary Outcomes (1)

  • Amount of maxillary molar distalization

    Measurements were made using miniscrew as a reference point. Digital measurements were made on Geomagic Studio 2014 software to evaluate the amount of maxillary molar distalization. All 3D digital model measurements were coded, and the same researcher carried out two separate measurements 1-week apart to increase the reliability of the measurements. Parallelism was ensured between the dental arch and the Y-axis on the side where the measurements would be made by guiding the models. The parallelism of the dental arch to the Y-axis was also assessed from the lateral view. The midpoint of the first miniscrew and the mesial edge of the maxillary first molar were marked in the occlusal view. Then the distance between the projections of these two reference points to the Y-axis was measured. The difference between the two consecutive measurements indicated the 3-week amount of distalization in T1, T2, T3 and T4. This procedure was applied on both sides of all 3D models

    84 days after

Study Arms (3)

Intervention (Laser group)

EXPERIMENTAL

The participants in the intervention group experienced a total of 7 session laser applications on their randomly determined molar region during the 12-week clinical trial period.

Device: Low Level Laser therapy

Contralateral (Non-laser group)

NO INTERVENTION

Laser was not applied to the contralateral side of the intervention group (n=10) and the individuals in the control group (n=10); thus, no application was made to accelerate tooth movement

Control (Non-laser group)

NO INTERVENTION

Laser was not applied to the contralateral side of the intervention group (n=10) and the individuals in the control group (n=10); thus, no application was made to accelerate tooth movement

Interventions

The participants in the intervention group experienced a total of 7 session laser applications on their randomly determined molar region during the 12-week clinical trial period.

Intervention (Laser group)

Eligibility Criteria

Age16 Years - 22 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Skeletal class I or mild class II malocclusion,
  • No untreated decayed teeth,
  • Normodivergent skeletal pattern,
  • Fully erupted maxillary first and second molars,
  • Male and female individuals between the ages of 16 and 22,
  • Extracted or congenitally missing maxillary third molars,
  • Non smoker,
  • No alveolar bone loss or periodontal disease,
  • Bilateral class II molar relationship,
  • Absence of crowding or spacing in the posterior region,
  • Adequate oral hygiene.
  • No drug usage that may have an impact on the biology of tooth movement (Example; Non-steroidal anti-inflammatory drugs- NSAIDS)

You may not qualify if:

  • Hypodivergent or hyperdivergent skeletal pattern,
  • Alveolar bone loss or periodontal disease,
  • Systemic illnesses that might affect bone metabolism,
  • Any drug use that may have an impact on the biology of tooth movement (Example; Non-steroidal anti-inflammatory drugs- NSAIDS),
  • Inadequate oral hygiene,
  • Unilateral class II molar relationship,
  • Smoker,
  • Severe class II skeletal malocclusion (ANB\>7°),
  • Crowding or spacing in the posterior region,
  • Missing maxillary second molars,
  • Existence of maxillary third molars,
  • Having untreated decayed teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beren Özsoy

Nicosia, Cyprus

Location

Related Publications (1)

  • Ozsoy B, Gulduren K, Kamiloglu B. Effect of low-level laser therapy on orthodontic tooth movement during miniscrew-supported maxillary molar distalization in humans: a single-blind, randomized controlled clinical trial. Lasers Med Sci. 2023 Feb 20;38(1):76. doi: 10.1007/s10103-023-03736-y.

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A clinical trial with experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMD, Research assistant

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 22, 2022

Study Start

January 29, 2021

Primary Completion

September 1, 2021

Study Completion

January 14, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations