Post-Endodontic Instrumentation Pain After in a Single Session Associated With Photobiomodulation (NCT06253767) | Clinical Trial Compass
CompletedNot Applicable
Post-Endodontic Instrumentation Pain After in a Single Session Associated With Photobiomodulation
Brazil58 participantsStarted 2022-10-20
Plain-language 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.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Baseline : Analysis of pain before treatment
Timeframe: Immediately before the treatment
2
Analysis of Postoperative Pain at 4 Hours After Treatment
Timeframe: 4 hours after treatment
3
Analysis of Postoperative Pain at 8 Hours After Treatment
Timeframe: 8 hours after treatment
4
Analysis of Postoperative Pain at 12 Hours After Treatment
Timeframe: 12 hours after treatment
5
Analysis of Postoperative Pain at 24 Hours After Treatment