Clinical trial NCT06129643: Post-operative Pain After Laser Root Canal Treatment of Necrotic Teeth With Apical Periodontitis
Official title: Post-operative Pain After Laser Root Canal Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulp Necroses
Apical Periodontitis
Pulp Disease, Dental
Keywords: laser in endodontics
post-operative pain
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2023-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.

Thirty patients are equally divided into 3 separate groups :

* Group A (Conventional): 2.5% NaOCL and 17% EDTA.
* Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
* Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient is given pain scale chart Numeric Rating Scale (NRS) to record his/her pain level before any endodontic treatment. All data will be collected, tabulated, summarized, and statistically analyzed.

Detailed description: Postoperative pain is a common complication following conventional endodontic treatment. According to a systematic review, the frequency of endodontic postoperative pain is between 3% and 58% of patients.Postoperative pain is attributed to chemical, mechanical and microbiological factors.

Residual microorganisms remaining due to the complexity of the root canal system and the limited penetration capability of conventional irrigants are directly responsible for Post operative pain The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.

Thirty patients are equally divided into 3 separate groups :

* Group A (Conventional): 2.5% NaOCL and 17% EDTA.
* Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
* Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient will be given pain scale chart (NRS scale) to record his/her pain level before any endodontic treatment. After disinfection, local anesthetic, tooth isolation, access cavity preparation and final obturation. Patients are asked to mark on a numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity at 6, 12, 24, 48, 72 hours, and 7 days after the procedure All data will be collected, tabulated, summarized, and statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients who had asymptomatic, single-rooted maxillary anterior teeth with necrotic pulp and periapical lesion with a periapical index score of 3 or 4
* Patients complaining of no pain and without fistulous tract
* Closed apex.
* Acceptance to participate in the study.

Exclusion Criteria:

* Antibiotic use within the last month, anti-inflammatory analgesic use within the last 5 d, systemic diseases or allergic reactions, calcified canals, root resorption, previous root canal treatment.
* Periodontal diseases, presence of swelling or fistulous tract.
* Vulnerable group including pregnant females, mentally or physically disabled individuals. - Technical difficulties during root canal treatment such as; curved roots, broken files, over instrumentation, overfilling or incomplete filling.

Primary outcomes:
measure: Postoperative pain assessment
timeFrame: Measure changes in post-operative pain 6 hours after intervention in the three groups using NRS
measure: Postoperative pain assessment
timeFrame: Measure changes in post-operative pain 12 hours after intervention in the three groups using NRS
measure: Postoperative pain assessment
timeFrame: Measure changes in post-operative pain 24 hours after intervention in the three groups using NRS
measure: Postoperative pain assessment
timeFrame: Measure changes in post-operative pain 48 hours after intervention in the three groups using NRS
measure: Postoperative pain assessment
timeFrame: Measure changes in post-operative pain 72 hours after intervention in the three groups using NRS
measure: Postoperative pain assessment
timeFrame: Measure changes in post-operative pain up to 7 days after intervention in the three groups using NRS
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
References: