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Laser treatment for healing after tooth extraction in patients who received radiotherapy for head and neck cancer - clinical trial

Use of photodynamic therapy in alveolar repair after tooth extraction in head and neck irradiated patients: randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-79gtzqq
Enrollment
Unknown
Registered
2025-02-28
Start date
2023-04-01
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

Osteoradionecrosis

Interventions

This is a non-randomized controlled clinical trial, with three arms, without blinding. Extractions will be performed on patients who received Radiotherapy in the head and neck region according to the
Pentoxifylline 400mg capsules for oral use 1 capsule every 8 hours (totaling 3 capsules per day) starting fifteen days before the extraction and continuing until suspended by the professional
Tocopherol 400mg capsules for oral use, 1 capsule every 8 hours (totaling 3 capsules per day) starting fifteen days before the extraction and continuing until suspended by the professional. Interventi
Intervention group 2 (antimicrobial photodynamic therapy), did not receive medication prescriptions prior to tooth extracti
E02.594.540

Sponsors

Sociedade Pèrnambucana de Combate ao Câncer
Lead Sponsor
Universidade Federal de Pernambuco
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Over 18 years old; both genders; presence of teeth with indication of simple extraction; history of radiation therapy to the head and neck; more than 3 months from the end of radiotherapy to the head and neck

Exclusion criteria

Exclusion criteria: Patients who underwent palliative radiotherapy or with any dose lower than 60Gy; patients who have used medications with antiresorptive potential or other cause likely to cause bone necrosis; patients with any known contraindication or allergy to methylene blue or some prescribed medications; patients whose Radiotherapy has not involved the region in which the tooth to be removed is included; patients with some clinical impediment to photobiomodulation (trismus, surgical sequelae)

Design outcomes

Primary

MeasureTime frame
It is expected that the group whose preventive intervention consisted of antimicrobial photodynamic therapy will present complete alveolar mucosal repair within the 28 days of evaluation.

Secondary

MeasureTime frame
It can be expected as a secondary advance that the group whose preventive intervention consisted of antimicrobial photodynamic therapy does not present alveolar mucosal compression repair within the 28 days of evaluation.

Countries

Brazil

Contacts

Public ContactRaylane de Albuquerque

Sociedade Pèrnambucana de Combate ao Câncer

raylanealbuquerque93@gmail.com+55(81)32178173

Outcome results

None listed

Source: REBEC (via WHO ICTRP)