A Phase 2 interventional study of Irrigation Solution in Post Operative Pain, sponsored by Armed Forces Institute of Dentistry, Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-21.
Sponsored by Armed Forces Institute of Dentistry, Pakistan · Phase 2, Interventional, and Treatment
This is a randomized , prospective , control trial to assess the effectiveness of intracanal cryotherapy on post operative pain after root canal treatment in patients with symptomatic apical periodontitis
Diagnostic procedures to include patients history taking , clinical and radiographic with all findings being recorded in patients .
patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical periodontitis.
patients will be asked to rate their pre treatment pain on visual analogue scale from 0-10
patients with pain score \<8 will be considered
Anesthesia and isolation : after administration of local anesthesia , rubber dam application will be done
Acess cavity : acess will be gained with round bur using air turbune handpiece with copious water cooling
Working length : a size 10k file will be inserted into the canal to determine the working length with the help of radiograph
Cleaning and shaping : Extirpation of pulp will be done followed by canal preparation with manual and endodontic motor using naocl and EDTA .
final irrigation will be performed using 17% EDTA and 5.25% NaOCl
Patients will be divided into 2 group in control group : final irrigation will be done using 5ml of saline at room temperature in cold group : final irrigation will be done using 5ml of cold saline at 2.5°C
the solution will be stored in the refrigerator until use irrigation will be performed for 5 min in both groups using 27 G beveled needle tip inserted 2mm short of WL.
Obturation ; In both groups , canals will be dried with paper points and obturated using gutta percha cones with zinc oxide eugenol sealer
Restoration : acces cavity will be restroed with direct composite restoration or high viscosity glass ionomer cement
each patient will be given instruction to acess the post operative pain .
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Armed Forces Institute of Dentistry, Pakistan is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In control group , canals will be irrigated with 5ml of normal saline at room temperature
Drug: Irrigation Solution
in cold saline group , canals will be irrigated with 5 ml of cold saline at a temperature of 2.5° C
Drug: Irrigation Solution
normal saline will be used as irrigation solution
Also known as: normal saline irrigant
post operative pain after root canal treatment
post operative pain will be assessed using visual analogue scale ( VAS) from 0-10 each patient will be given instruction to access the post operative pain . it will be carried out using a questionnaire. VAS 0-1 = No pain 2-3 = mild pain 4-6 = moderate pain 7-10 = severe pain pain recording will be done at 6 hrs , 24 hrs, 48hrs and 72 hrs. ( participants to be contacted by investigator at each point to check on them and remind them to record their pain ). The given questionnaire shall be collected when the participant comes for final restoration after 1 week
Time frame: 1 week
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Armed Forces Institute of Dentistry, Pakistan