Clinical trial NCT05840679: Different Concentrations of Sodium Hypochlorite Affecting Post-endodontic Pain
Official title: Effect of Different Concentrations of Sodium Hypochlorite on Post Operative Pain Following Single Visit Root Canal Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Post Operative Pain
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, prospective, double-blind, clinical trial to assess the effect of 3% and 6% sodium hypochlorite (NaOCl) as irrigant on postendodontic pain and rescue medication intake following single visit root canal treatment

Detailed description: Diagnostic procedures to include history taking and clinical and radiographic examination with all findings being recorded in patient's notes.

• A prolonged exaggerated response (more than 10 seconds) to a cold pulp sensibility test and a positive response to the electric pulp tester will be considered evidence for irreversible pulpitis.

Patients will be asked to rate their pre-treatment pain on a visual analogue scale from 0 to 10.

Patients with moderate pain will be selected, VAS score (4 - 6).

* ANESTHESIA Patients receive 2 cartridges of 2% Articaine with 1:80000 epinephrine in an Inferior Alveolar Nerve Block Injection
* Access opening, isolation and first rinse with NaOCl After access preparation, each tooth will be isolated using rubber dam. Patients will be randomly assigned to either of the following groups: 3% NaOCl or 6% NaOCl. The pulp chamber will be filled with 2mL irrigant for 2 min followed by saline irrigation.
* Hand Instrumentation The patency of canals will be established and an initial glidepath be prepared using size 10 and 15 K-files (Mani, Mani Inc., Tochigi, Japan)
* WORKING LENGHT WL will be determined using apex locator (DentaPort ZX, J.Morita USA) and confirmed radiographically to be 1 mm short of the radiographic apex.
* ROTARY INSTRUMENTATION Mechanical prep using a Niti rotary system (Protaper Universal, Dentsply Sirona) in a torque-controlled endodontic motor (X-Smart plus, Dentsply Maillefer) according to the manufacturer's sequence and recommendations of speed and torque. Canal prep with S1 and SX instruments in a crown-down sequence to shape the coronal two-thirds of canal.
* APICAL PREPARATION Apical patency will be maintained with a size 10 K file before each rotary-instrument change.The apical preparation will be done using S1, S2, F1 or F2 up to WL corresponding to tip size of F1 or F2.
* IRRIGATION
* Between instruments, the root canals will be irrigated with 2 mL of either 3% or 6% NaOCl with a 30G x 25mm side-perforated needle (Medic Endo Irrigation Needles, HDS).
* The tip of the needle will be kept 4mm short of WL. The needle will be repeatedly moved up and down in order to prevent locking in the canals.
* Volume of irrigant use after every instrumentation - 2ml
* Total volume of NaOCl used per canal - 8-10ml , per Tooth - 24 - 30 ml
* After NaOCl, canals will be flushed with 5ml normal saline irrigation.
* Smear layer will be removed by irrigation with 17% EDTA, (EDTA; Glycle File Prep, Dentsply Maillefer) followed by 5 mL normal saline irrigation.
* DRYING CANALS At the same visit, the root canals will be dried with paper points (GAPADENT Absorbent paper points)
* OBTURATION Shall be filled with matched size gutta-percha cones (Meta Biomed Co, Korea) and sealar (Endoplus Root Canal Sealer 13,5g President Dental Germany) using the single cone technique.
* Sealed with Temporary restoration (Cavit, 3M ESPE, Germany) Patients will receive a rescue bag of 10 Ibuprofen in case they have pain with instructions for ondemand use.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals between 18 to 55 years
* First and second mandibular molar diagnosed with irreversible pulpitis due to caries
* Patients with moderate pain will be selected, VAS score (4 - 6).
* Normal periapical radiographic appearance
* Mild tender to percussion
* No allergies to articaine

Exclusion Criteria:

* Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit
* Pregnant or lactating patients
* Teeth with severe periodontal disease
* Teeth that cannot be isolated with rubber dam
* Teeth undergone over-instrumentation or overfilling beyond apex
* Teeth with calcifications/ resorptive defects
* History of allergy to any materials used in the study

Primary outcomes:
measure: Post-operative pain after root canal treatment
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institue Of Dentistry
state: Punjab
Study officials:
References: