Velásquez, Sergio Andrés
López Anaya, Liliana
Domínguez, Angela
Dipp Velázquez, Farid Alfonso
Castillo Silva, Brenda Eréndida
Article History
Received: 5 October 2025
Accepted: 7 December 2025
First Online: 5 January 2026
Declarations
:
: Not applicable.
: This clinical study was conducted in full accordance with the ethical principles outlined in the Declaration of Helsinki and the national regulatory framework for health research in Mexico. The protocol was reviewed and approved by the Ethics and Biosecurity Committee of the Faculty of Stomatology at the Benemérita Universidad Autónoma de Puebla (BUAP), under the supervision of the postgraduate program in Orthodontics. All participants provided written informed consent prior to enrollment, in compliance with Article 13 and Article 16 of the General Health Law for Research in Mexico. These articles emphasize the protection of human dignity, privacy, and autonomy in studies involving human subjects. The consent process included verbal and written explanations of the study’s objectives, procedures, potential risks, and benefits. Participants were informed of their right to withdraw from the study at any time without affecting their access to orthodontic care. The study adhered to the following official Mexican standards issued by COFEPRIS and the General Health Council: - NOM-012-SSA3-2012: Ethical and methodological requirements for health research involving human subjects - NOM-241-SSA1-2012: Good clinical practices for clinical research - NOM-220-SSA1-2016: Guidelines for the establishment and operation of ethics committees in health research.- NOM-035-SSA3-2012: Standards for informed consent and participant information in health research, No financial compensation was provided to participants. All data were handled confidentially and used exclusively for research purposes. The study was designed to minimize risk and discomfort, and no permanent alterations to orthodontic treatment protocols were introduced.
: It is imperative that future randomized clinical trials will included a bigger sample in order to understand the complexity kinetics of the SP in the crevicular fluid during orthodontic movement with and without PBM application.
: The authors declare no competing interests.