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Use of Laser in the healing of teeth Removal of patients submitted to Dental extraction after Radiotherapy in the head and neck region

Use of Photobiomodulation in the Alveolar Repair of patients submitted to Exodontia after Radiotherapy in the head and neck region a double blind and randomized clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-7pz64y
Enrollment
Unknown
Registered
2019-06-11
Start date
2017-10-01
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

The objective of this study was to evaluate the efficacy of photobiomodulation (PBM) in the alveolar mucosa covering of patients submitted to simple exodontia after head and neck radiotherapy (RT-CP).
• D14 (14 post-operative days)
• D21 (21 post-operative days)
• D7 (28 post-operative days)
The following data were evaluated: pain, need for analgesic administration, presence of post-operative infection, post-surgical bone exposure, and time taken for complete mucosal lining of the post-su
Procedure/surgery

Sponsors

Thyago Morais Vicente da Silva
Lead Sponsor
Hospital de Câncer de Pernambuco - HCP
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Were over 18 years of age; had presence of teeth requiring simple extraction; had a history of radiotherapy in the head and neck with a minimum of 60Gy in the maxilla and/or mandible; over 3 months since the conclusion of radiotherapy in the head and neck.

Exclusion criteria

Exclusion criteria: Patients allergic to penicillin, individuals with systemic compromise that would contraindicate the surgical procedure, in addition to patients undergoing palliative treatment, without the indication of surgical intervention.

Design outcomes

Primary

MeasureTime frame
Expected outcome: Alveolar mucosal recoating in a shorter time after exodontia in patients submitted to radiotherapy in the head and neck region. With the application of photobiomodulation and the use of antibiotic therapy, patients will be evaluated clinically every 7 days for a period of 28 days, verifying through the clinical examination the evolution of the alveolar mucosal covering after the dental extractions, where we expect to observe a longer time rapid healing of the dental alveolus with the use of photobiomodulation.

Secondary

MeasureTime frame
Expected outcome 1: Lower risk of postoperative infection. With the application of photobiomodulation, a faster alveolar healing is expected, consequently a shorter time of alveolar bone exposed to the buccal medium, thus leading to a lower risk of post-surgical infection. The presence of infection after exodontia was verified through clinical examination every 7 days for a period of 28 days.;Expected outcome 2: Less postoperative pain. With the use of photobiomodulation as an adjuvant treatment for the treatment of maxillary osteonecroses, since it provides an increase in local vascularization, greater absorption of inflammatory enzymes and reduction of edema, it is expected that its applicability will provide less pain after the Exodontia. It was verified with the application of a numerical visual scale graded from left to right in unit values of 0 (no pain and no functional complaint) to 10 (unbearable pain and severe oral functional impairment). The scale will be classified in 4 grades according to the result: no complaint (value equal to 0), mild (value from 1 to 2), moderate (from 3 to 7) and severe (from 8 to 10), evaluating each 7 days for a period of 28 days.; 899/5000 Expected outcome 3: Need for administration of analgesic. Photobiomodulation has been used in studies over the years, providing good results in pain relief, edema reduction capacity and accelerating the tissue repair process in both non-irradiated patients and those at risk of osteorradionecrosis of the jaw. Being its effective application in soft and bony tissues in the modulation of the inflammation, accelerating the cellular proliferation the wound repair process and the control of the pain. Therefore, it is expected that patients undergoing photobiomodulation will use less analgesics to control postoperative pain after the exodontia, being verified through the application of a questionnaire to the patient every 7 days during 28 postoperative days, where they will inform if there was a n

Countries

Brazil

Contacts

Public ContactThyago Morais

Universidade Federal de Pernambuco

thyago_morais@hotmail.com+55 81 996866091

Outcome results

None listed

Source: REBEC (via WHO ICTRP)