Home » Trials » SLCTR/2025/026
Effect of chairside photobiomodulation on pain following clear aligner therapy: A randomized sham-controlled clinical trial
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SLCTR Registration Number
SLCTR/2025/026
Date of Registration
The date of last modification
Sep 25, 2026
Scientific Title of Trial
Effect of chairside photobiomodulation on pain following clear aligner therapy: A randomized sham-controlled clinical trial
Public Title of Trial
Effect of chairside photobiomodulation on pain reduction following clear-aligner change in adults undergoing clear-aligner therapy compared with sham treatment: A randomized sham-controlled clinical trial
Disease or Health Condition(s) Studied
Orthodontic pain associated with clear-aligner change
Scientific Acronym
ALIGN-PBM
Public Acronym
ALIGN-PBM
Brief title
Immediate Photobiomodulation for Pain After Aligner Change
Universal Trial Number
U1111-1335-7508
Any other number(s) assigned to the trial and issuing authority
ERC - ODC research ODC-PG-NM-2025-234P3
What is the research question being addressed?
In adults undergoing clear-aligner therapy, does immediate chairside photobiomodulation (660 nm) delivered after aligner insertion reduce patient-reported pain (at rest and on biting/chewing) during the first 48 hours after an aligner change compared with a sham procedure?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
The study will be conducted at the orthodontic department, oman dental college, Muscat, Oman.
Randomization
a. participants will be allocated using simple computer-generated randomization in 1:1 ratio into either the active PBM group or the sham control group.
b. the individual participants will be the unit of randomization
c. A computer-generated randomization sequence will be prepared prior to participant recruitment using random allocation software.
d. Allocation concealment will be achieved using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher not involved in outcome assessment or intervention delivery
Intervention
Active arm: The active intervention consists of immediate chairside photobiomodulation (PBM) delivered after insertion of a new clear aligner using a 660-nm diode laser (SiroLaser Blue, Dentsply Sirona; red-light mode). PBM will be applied intraorally according to a standardized application map involving 12 sites per arch (24 sites total when both arches are treated). The laser tip will be applied in contact mode over gingival tissues adjacent to the teeth undergoing movement. Exposure time and energy delivery will be standardized equally across all sites. The intervention will be delivered once immediately after aligner insertion.
Control arm: The sham control group will undergo an identical clinical procedure, including the same intraoral application protocol, duration, tip placement, and workflow, but without therapeutic light emission.
This study will be conducted as a participant- and assessor-blinded randomized clinical trial. Participants will be blinded to group allocation, and outcome assessors responsible for data collection and analysis will also remain blinded throughout the study. The sham procedure is designed to mimic the active PBM intervention to maintain participant blinding. The operator delivering the intervention cannot be blinded due to the nature of the procedure but will not be involved in outcome assessment or statistical analysis.
Inclusion criteria
Exclusion criteria
Use of analgesics or anti-inflammatory medication within 24 hours before baseline (unless medically necessary) Chronic pain condition or use of pain-modulating medications Known photosensitivity condition/medication per local screening policy Oral mucosal pathology requiring treatment at baseline Pregnant or lactating (if required by institutional policy) Any contraindication to diode laser procedures under local laser safety policy
Primary outcome(s)
|
1.
Pain intensity (0–10 Numeric Rating Scale, NRS) recorded as: pain at rest and pain on biting/chewing. |
[ 6 hours, 24 hours, and 48 hours after aligner insertion (aligner change) ] |
Secondary outcome(s)
|
1.
Analgesic consumption within 48 hours (any use yes/no; number of doses; medication type and dose if available). |
[ 0–48 hours after aligner insertion. ] |
|
2.
Aligner fit/tracking score assessed by blinded assessor using standardized criteria supported by standardized intraoral photographs. |
[ Day 7 after aligner insertion. ] |
Target number/sample size
17 participants in the active PBM group and 17 participants in the sham control group (total n = 34).
Countries of recruitment
Oman
Anticipated start date
2026-10-15
Anticipated end date
2027-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University foundation
Regulatory approvals
ethics, research & innovation committee ( ERIC), Oman dental college, muscat, Oman
Status
Approved
Date of Approval
2026-02-22
Approval number
ODC-PG-NM-2025-234P2
Details of Ethics Review Committee
| Name: | Ethics, Research & Innovation Committee (ERIC) |
| Institutional Address: | Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oma |
| Telephone: | 0096824665555 |
| Email: | research@staff.odc.edu.om |
Contact person for Scientific Queries/Principal Investigator
Dr. Noora Al Mataani
principle investigator - resident orthodontist
Orthodontic department, Oman dental college, muscat, oman
+96877160244
nalmataani@pg.odc.edu.om
Contact Person for Public Queries
Dr. Noora Al Mataani
principle investigator - resident orthodontist
Orthodontic department, Oman dental college, muscat, oman
+96877160244
nalmataani@pg.odc.edu.om
Primary study sponsor/organization
Oman dental college
Oman Dental college, al wattayah, muscat 116, sultanate of Oman
+968 24665555
info@odc.edu.om
Www.odc.edu.om
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
De-identified individual participant data (pain scores at rest and on chewing at 6 h/24 h/48 h; analgesic use variables; day-7 tracking score; and baseline covariates) will be available upon reasonable request after publication of the primary results. Requests will be reviewed by the study team and the sponsor (Oman Dental College). Data will be shared in a de-identified format with a data-sharing agreement, for non-commercial research purposes, and will not include direct identifiers.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
