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Effect of laser therapy in the treatment of paresthesia in patients undergoing orthognathic surgery and wisdom tooth extraction

Effect of photobiomodulation in the treatment of paresthesia in patients undergoing orthognathic surgery and third molar extraction: randomized, triple-Blind, controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4gkp27w
Enrollment
Unknown
Registered
2025-01-28
Start date
2023-10-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parestehesia

Interventions

This is a two-arm, triple-blind, randomized controlled clinical study. Participants will be placed into 3 groups, through a draw,with 40 participants allocated per group. The 3 groups will be: 1, 2, 3
the chin, cheeks, lips and gums will also be irradiated. Group 2: 40 participants will receive photobiomodulation therapy, 660 and 808 nm, simultaneously, 100mW, 20s/point, 2J of energy/point of each
the chin, cheeks, lips and gums will also be irradiated. Group 3: 40 participants will receive the photobiomodulation therapy simulation with the laser used in off mode (sham), distance of 1 cm betwe
The chin, cheeks, lips and gums will also be irradiated. The laser application will be carried out by a trained researcher, using equipment that applies light to the tissues to be treated, at pre-esta
E02.594.540
E02.190

Sponsors

Faculdade de Odontologia da Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Will be included, adults aged between 18 and 60 years; of both sexes and regardless of color or social class; with a main complaint of inferior alveolar nerve paresthesia who underwent orthognathic surgery or third molar extraction; who seek or are referred to "Laboratório Especial de Laser em Odontologia da Universidade de São Paulo" for the treatment of paresthesia; to all participants will be asked to sign the free and informed consent form

Exclusion criteria

Exclusion criteria: Participants with paresthesia unrelated to orthognathic surgery or third molar extraction will be excluded; patients who also present lingual nerve paresthesia; patients with sensory changes reported before surgery or with a history of injury to trigeminal nervous tissue due to other interventions; patients who present paresthesia of the maxillary and/or mandibular branches of the trigeminal nerve and are undergoing some other type of treatment for paresthesia (Acupuncture; systemic medication; local physiotherapy; electrical stimulation); be using antidepressant or anxiolytic medications, and pregnant women

Design outcomes

Primary

MeasureTime frame
Evaluate improvement in inferior alveolar nerve paresthesia after photobiomodulation therapy, using sensitivity assessment forms, visual analogue scale (VAS) and Oral Health Impact Profile (OHIP-14)

Secondary

MeasureTime frame
no secondary outcome is expected

Countries

Brazil

Contacts

Public ContactIsabella Polho

Faculdade de Odontologia da Universidade de São Paulo

isabella.polho@usp.br+55 11 3091-7418

Outcome results

None listed

Source: REBEC (via WHO ICTRP)