CTRI

· This is an in vivo experimental, prospective, single-blinded randomized controlled trial with a 1:1:1 allocation ratio

· Patients attending the Out-Patient Department (OPD) of CONSERVATIVE DENTISTRY, ESTHETICS, AND ENDODONTICS in Manubhai Patel Dental College and Dental Hospital, Vadodara with a complaint of moderate to severe pain in their mandibular molar teeth and ready to give their consent will be considered in the study Participants in each group will be allocated by Lottery system.

· The outcome assessor will be blinded (single blinded) to the procedure , the participants and the operator will not be blinded owing to the difference in the modalities employed for the treatment and variations in the steps involved while performing the procedure.

Patients will be confirmed with the above inclusion criteria and checked whether ready to participate in the randomized clinical trial by giving consent. Patients will be informed about the localized side effects of submucosal dexamethasone injection (soreness, mild discomfort, minor localized swelling and hypopigmentation). Patients aged between 15 to 65 years will be included in the study. The patient will be explained about the treatment, the alternative treatment and the risks involved and an informed consent will be given to the patient which will be signed by the patient giving the consent. Only the patients giving their consent for the clinical trial will be included in the study and will randomly be divided into three groups (the three groups will be standardized in terms of age, gender, type of tooth, root curvature and severity of pain before treatment) by Lottery method and be scheduled for multi-visit root canal treatment.

The patients’ demographic data including age, gender and tooth number will be recorded. Patients will be provided with two non-numeral 170mm Heft-Parkar VAS to record their tooth pain and percussion pain separately (scores less than 56 mm will be included).

The procedure will be started with administration of local anaesthesia using inferior alveolar nerve block by injecting 1.8ml of 2% lidocaine with 1:2,00,000 epinephrine and submucosal infiltration of 0.8 ml of 4% Articaine with 1:2,00,000 epinephrine. After achieving adequate anaesthesia, rubber dam isolation will be performed and an access cavity will be prepared using a round bur and high-speed hand-piece under water and air spray. Class 2 cavities will be converted into Class 1 cavities by doing Pre-endodontic build-up.

After performing patency filing, the working length of the canals will be determined by introducing a #15 K-file into the canals using Root ZX apex locator (J Morita); the # 15 K-file will be kept at the length corresponding to the reading of the apex locator denoted as 1; which will be confirmed by digital radiography. The root canals will be prepared using Rotary System as per apical constriction and initial binding file and biomechanical preparation will be completed using crown-down method.

During the root canal preparation, 2.5% sodium hypochlorite will be used for canal irrigation and 5 ml of 1% sodium hypochlorite, followed by 5 ml of 17% EDTA, each for 1 minute, will be used for smear layer removal. The irrigant will be activated using Sonic Endo Activator (Glin) with the motor switch being set to 10,000 cycles per minute for 30-60 seconds in each canal. A final rinse will be performed with saline at room temperature. The canals will be dried with absorbent paper points ; calcious hydroxide intracanal medicament will be place and access cavity will be temporized with temporary restorative material.

After completion of biomechanical preparation , the patients already divided into three groups of Low-level Laser Therapy, Submucosal Dexamethasone injection and Control groups respectively; by lottery method will undergo the respective treatment.

Group 1: Submucosal Dexamethasone injection after BMP in 1^st visit

Group 2: Low Level Laser therapy after BMP in 1^st visit

Group 3: BMP followed by neither of the adjunctive modalities but oral analgesic is prescribed (Control group)

The patients will be requested to rate their pain immediately after treatment and then at 6hrs, 12hrs, 24hrs, 48hrs, and 72hrs post-operatively. The scores will be made in a pain diary handed over to the patients. In addition, the follow up of the patients over the phone at regular intervals to ensure that the pain rating will be done and made a note of it, to minimize the chance of any missing data. All the patients will be provided with rescue medicines for the event of any post-instrumentation pain.

GROUP 1: SUBMUCOSAL DEXAMETHASONE INJECTION AFTER BMP IN 1^ST VISIT

After the completion of BMP in the first visit following the above mentioned protocol;

The first group will be subjected to Submucosal Dexamethasone injection - 1ml (4mg) of Dexamethasone (Dexona) will be deposited slowly in the buccal vestibule close to the root apex of the targeted tooth with 5ml 30 gauge short needle.

GROUP 2: LOW LEVEL LASER THERAPY AFTER BMP IN 1^ST VISIT

After the completion of BMP in the first visit following the above mentioned protocol;

The second group will be subject to Low-level Laser Therapy by laser irradiation performed using 980-nm diode laser (Rise Medicare) 0.5 W power and a tip diameter of 10 mm for 15 seconds. The laser will be irradiated to the soft tissues covering the mesial and distal apices of the tooth from buccal as well as lingual sides for 15 seconds at each site with the tip of the laser handpiece held at a distance of approximately 10 mm from the mucosa. The fibre tip of the laser will be positioned perpendicular to the surface and close to the soft tissue.

GROUP 3: - BMP IN 1^ST VISIT WITHOUT ANY ADJUNCTIVE MODALITY BUT ORAL ANALGESIC IS PRESCRIBED (CONTROL/ PLACEBO GROUP)

In the third group, BMP will be completed in the 1^st visit as per the above mentioned protocol and the subjects will not be exposed either to Low-level laser therapy or Submucosal Dexamethasone injection but will be prescribed with oral analgesic medication. (Combiflam tablets [Ibuprofen (400mg) and Paracetamol (325mg)] will be prescribed)

The patients will not be prescribed analgesics in the first two groups unless they report with severe post-operative pain. In case of severe post-operative pain in the first two groups, Combiflam tablets [Ibuprofen (400mg) and Paracetamol (325mg)] will be prescribed to each patient along with the instructions for use. They will also be asked to record the number of analgesics required. If patients report taking an analgesic, they will be excluded from the study and replaced.

when the patient will be assessed clinically to check for intra-oral complications and percussion test will be done to check the periapical status. In the next visit Root canals will be filled with gutta-percha and Bioceramic root canal sealer (Bioactive Root Canal Sealer; Safe Endo) with warm vertical compaction technique (Orikam Fast pack and Fast fill devices) in the second visit ; the quality of obturation would be checked by taking final Intaoral Periapical Radiographs.

Endodontically-treated teeth shall not be reduced out of contact with the opposing teeth. Teeth with technical problems and procedural errors such as perforation, canal transportation, missed canals and poor quality of obturation shall be excluded.

Post-obturation the canal orifices will be sealed with flowable composite material (Safe Endo) and access cavity will be temporarily sealed with a temporary restorative material

The patients will be instructed to make a note of the time at which they took the rescue medicine in the pain diary, to estimate the duration of pain relief. The duration of pain relief will be calculated as the time interval between the completion of the first visit and the time of need of rescue medicine or endpoint of the postoperative assessment. The patients will be requested to return the pain diary when they report for the next visit.