Clinical trial NCT06253767: Post-Endodontic Instrumentation Pain After in a Single Session Associated With Photobiomodulation
Official title: Analysis of Post-Endodontic Instrumentation Pain in Molars and Premolars Treated in a Single Session Associated With Photobiomodulation: A Double-blind Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Endodontically Treated Teeth
Keywords: photobiomodulation
analgesia
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2024-02-12
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect f PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group with conventional treatment with photobiomodulation and the Control Group with conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.

Detailed description: The randomized clinical trials conducted in recent years have demonstrated that photobiomodulation (PBM) modulates postoperative pain in endodontic instrumentation, especially in the first days after the procedure. Although the results are promising, there is still low-quality evidence regarding the best dosimetric parameter applied. The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect of PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group (n=29): conventional treatment with photobiomodulation (808 nm, 100mW power, 3J per point, 3mm2 area, 3 points in the region of the root apices - two vestibular and one palatal, total energy of 9J - for molars and premolars 2 points - 1 vestibular and another palatal, total energy of 6J) and Control Group (n=29): conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.

Eligibility criteria: Inclusion Criteria:

* Patients with endodontic involvement in three-rooted (upper molars) or two-rooted (upper premolars) teeth.
* Age between 20 and 75 years.
* Both genders.

Exclusion Criteria:

* Pregnancy or lactation.
* Patients with oncological, renal, or Type I or Type II diabetes.
* Drug users; alcohol or tobacco users.
* Immunocompromised patients or those using immunosuppressive medication.
* Use of alendronate, bisphosphonates, or any systemic medication that interferes with bone metabolism.
* Presence of associated periodontal disease.
* Frequent exacerbations.
* Radiolucency images with PAI stages 3, 4, or 5 (Orstavik et al., 1986).
* Any other anatomical variation that renders single-session endodontic treatment unfeasible.
* Teeth with previous endodontic treatment.
* Patients with asymptomatic non-microbial apical periodontitis with any type of bruxism (clenching) or using a bite splint.
* Teeth with more than ⅔ coronal involvement, making proper use of rubber dam isolation impossible.
* Use of antibiotics in the last three months.
* History of severe allergy to chlorine or its derivatives.

Primary outcomes:
measure: Baseline : Analysis of pain before treatment
timeFrame: Immediately before the treatment
measure: Analysis of Postoperative Pain at 4 Hours After Treatment
timeFrame: 4 hours after treatment
measure: Analysis of Postoperative Pain at 8 Hours After Treatment
timeFrame: 8 hours after treatment
measure: Analysis of Postoperative Pain at 12 Hours After Treatment
timeFrame: 12 hours after treatment
measure: Analysis of Postoperative Pain at 24 Hours After Treatment
timeFrame: 24 hours after treatment
Secondary outcomes:
measure: Baseline : Analysis of pain upon palpation before treatment
timeFrame: Immediately before the treatment
measure: Analysis of Palpation Pain 24 Hours After Treatment
timeFrame: 24 hours after treatment
measure: Baseline: Analysis of pain upon percussion before treatment
timeFrame: Immediately before the treatment
measure: Analysis of Percussion Pain 24 Hours After Treatment
timeFrame: 24 hours after treatment
measure: Analysis of the Required Analgesic Quantity
timeFrame: 24 hours after treatment
measure: Oral Health Impact Profile-14
timeFrame: 24 hours after treatment
measure: Prevalence Analysis
timeFrame: 24 hours after treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Anna Carolina RT Horliana
role: STUDY_CHAIR
References: