Clinical trial NCT05935306: Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery
Official title: Effect of Photobiomodulation to Reduce Post-operative Pain After Endodontic Surgery: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photobiomodulation
Endodontic Disease
Pain
Inflammation
Surgery
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized, controlled, double-blind superiority clinical trial meets the criteria for designing a clinical trial in accordance with the SPIRIT Statement. It was accepted by Research Ethics Committee (CEP) of the Catholic University of Uruguay
Primary purpose: TREATMENT

Brief summary: The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled and double-blind clinical study, 34 patients without comorbidities who need endodontic surgery in the upper jaw (15 to 25 teeth) will be recruited. They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) a FBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analog scale at all postoperative control visits (baseline, 24 hours and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient's need (will be provided by the investigator).. Radiographic images will be obtained after 1 and 2 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extra-oral maxilla will also be evaluated. In addition, a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd month respectively.

Detailed description: Photobiomodulation (FBM) has shown favorable results in the postoperative period of endodontic surgery, however, up to now, the level of evidence in this procedure is low. The objective of this study will be to evaluate if photobiomodulation (FBM) can reduce postoperative pain in patients who will undergo endodontic surgery. For this randomized, controlled, and double-blind clinical study, 34 Uruguayan participants of both sexes who previously consulted at the Clínica Universitaria de la Salud, with a diagnosis of periodontitis with an apical lesion less than 10mm with or without a fistula, diagnosed clinically and radiographically, in the upper maxillary region (from 15 to 25) will be recruited. Participants included in the study must have periapical lesions who have already undergone endodontic treatment (lesions smaller than 10mm in their greatest diameter - Metin et al., 2018, single and chronic lesions), no comorbidities, age from 18 to 70 years, both genders, healthy permanent teeth with good hygiene. Participants will be excluded if they are taking drugs that affect bone metabolism and the inflammatory process (for example corticosteroids, bisphosphonates), Smokers, pregnant or lactating women, if used anti-inflammatory drugs in the last 3 months before surgery, who do not follow the guidelines or have an injury in the acute phase (pain, edema, exudate). They will be randomly divided into an experimental group (n = 17) photobiomodulation (808nm, 100 mW, and 4J/cm2 with 5 points per vestibular). Applications will be made in the immediate postoperative period and 24 hours after surgery. Control group (n = 17) FBM simulation will be performed in the same way as in the experimental group. In this group, the required analgesia will be administered within the standard with ibuprofen. Both groups will perform the necessary conventional procedures considered the gold standard in the literature. Both the patient and the evaluator will be blinded to the intervention performed. The primary outcome variable of the study will be postoperative pain, which will be assessed using the visual analog scale at all postoperative control visits (baseline, 24 hours, and 7 days). As for the secondary outcome variables, the amount of systemic medication received according to the patient's need (will be provided by the investigator). Radiographic images will be obtained after 1 and 3 months for evaluation of the repair (dimensions of the lesion, radiopacity). These radiographs will be taken digitally with the positioners implemented. Edema, ecchymosis, and evaluation of soft tissues in the anterior portion of the intra and extra-oral maxilla will also be evaluated. In addition, the temperature with a digital thermometer. These parameters will be evaluated 24 hours and 7 days after the intervention. The X-rays will be taken in the 1st and 3rd months, respectively. Once all the data have been collected, their normality will be tested, and the one-way ANOVA test and the complementary Tukey test will be carried out. Data will be presented as mean ± standard deviation (SD) and the accepted p-value will be \<0.0

Eligibility criteria: Inclusion Criteria

:• Patients with periapical lesions who have already undergone endodontic treatment (lesions smaller than 10mm in their greatest diameter - Metin et al., 2018, single and chronic lesions)

* Patients with not comorbidities,
* Age from 18 to 70 years,
* Both genders,
* Healthy permanent teeth with good hygiene.

Exclusion Criteria:

* Who are taking drugs that affect bone metabolism and the inflammatory process (for example: corticosteroids, bisphosphonates),
* Smokers, pregnant or lactating women,
* Who used anti-inflammatory drugs in the last 3 months before surgery.
* Who for any reason interrupted the evolution of the treatment for not attending joint appointments.
* Patients who do not follow the guidelines or have an injury in the acute phase (pain, edema, exudate)

Primary outcomes:
measure: Pain in postoperative period - baseline
timeFrame: Baseline (Before the intervention)
measure: Pain in postoperative period - 24 hours after treatment
timeFrame: 24 hours after treatment
Secondary outcomes:
measure: Pain in postoperative period - 7 days after treatment
timeFrame: 7th days after treatment
measure: Quantity of analgesics taken in the specific periods - baseline
timeFrame: Baseline (Before the intervention)
measure: Quantity of analgesics taken in the specific periods - 24 hours after treatment
timeFrame: 24 hours after treatment
measure: Quantity of analgesics taken in the specific periods - 7 days after treatment
timeFrame: 7 days after treatment
measure: Edema - baseline
timeFrame: Baseline (Before the intervention)
measure: Edema - 24 hours after treatment
timeFrame: 24 hours after treatment
measure: Edema - 7 days after treatment
timeFrame: 7 days after treatment
measure: Ecchymosis - baseline
timeFrame: Baseline (Before the intervention)
measure: Ecchymosis - 24 hours after treatment
timeFrame: 24 hours after treatment
measure: Ecchymosis -7 days after treatment
timeFrame: 7 days after treatment
measure: Soft tissue healing - baseline
timeFrame: Baseline (Before the intervention)
measure: Soft tissue healing - 24 hours after treatment
timeFrame: 24 hours after treatment
measure: Soft tissue healing -7 days after treatment
timeFrame: 7 days after treatment
measure: Bone consolidation - baseline
timeFrame: Baseline (Before the intervention)
measure: Bone consolidation - 1 month
timeFrame: 1 month
measure: Bone consolidation - 3 months
timeFrame: 3 months
measure: Local temperature - baseline
timeFrame: Baseline (Before the intervention)
measure: Local temperature - 24 hours after treatment
timeFrame: 24 hours after treatment
measure: Local temperature - 7 days after treatment
timeFrame: 7 days after treatment
measure: Sistemic temperature - baseline
timeFrame: Baseline (Before the intervention)
measure: Sistemic temperature - 24 hours after treatment
timeFrame: 24 hours after treatment
measure: Sistemic temperature - 7 days after treatment
timeFrame: 7 days after treatment
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Universidade Catolica do Uruguay
Study officials:
References: