A Phase 2 interventional study of Anti-inflammatory drug (ibuprofen) and Anti-inflammatory drug (dexamethsaone) in Post-endodontic Pain, Ibuprofen and Dexamethasone, sponsored by Armed Forces Institute of Dentistry, Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-20.
Sponsored by Armed Forces Institute of Dentistry, Pakistan · Phase 2, Interventional, and Treatment
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain with symptomatic irreversible pulpitis
Study will be conducted after the approval of Institutional Ethics Review Committee, AFID (ANX "A").
A total of 130 entitled patients reporting to Operative Dentistry Department, Armed Forces Institute of Dentistry will be invited for participation in this study. The procedure will be explained to the patients and their parents in Urdu language and a written informed consent will be taken (ANX "B") They will be screened for inclusion by taking history, performing relevant clinical examination and necessary tests along with peri-apical radiographs. Patients fulfilling the inclusion criteria will be divided into two groups using consecutive non random sampling.
Group 1: Patients treated with premedication of Non steroidal anti inflammatory drug (Ibuprofen) Group 2: Patients treated with premedication of Steroidal anti inflammatory drug (Dexamethsone)
Both groups will receive medication 15 mins before intiating root canal treatment. Root canal treatment will then be initiated under local anesthesia and rubber dam isolation. Working length will be taken 1mm from radiographic apex with apex locator and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Next system under copious irrigation with 5.25% sodium hypochlorite (NaOCl). Patency will be confirmed with a #10 K file between each instrument change. The root canals will be flushed with 5 mL of 17% EDTA solution. To control the microbiological impact on post-operative pain calcium hydroxide will be used as an intra-canal medicament and likewise 5.25% sodium hypochlorite as an irrigant in both groups. Following instrumentation and calcium hydroxide placement in the canal using lentulo spirals, the cavity will be temporarily sealed with cavit.
At the end of every appointment, patient will be given a visual analogue scale. The patient will be advised to mark the line corresponding with the intensity of his pain at 24, 48 and 72 hours after the first visit. The patient will be recalled after one week for obturation and final full coverage restoration. Analgesics will be prescribed in case of severe intolerable pain.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 130 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Armed Forces Institute of Dentistry, Pakistan is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain
Drug: Anti-inflammatory drug (ibuprofen)
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain
Drug: Anti-inflammatory drug (dexamethsaone)
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
Time frame: 24 hours
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
Time frame: 48 hours
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain
Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale
Time frame: 72 hours
Plan to share: Undecided
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Started Feb 2025 (actual). Primary completion is estimated for Jun 2025, 4 months after the start.
Of 124 non-industry phase 2 interventional studies under Pain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's planned 4 months is below that.
Counting every sponsor, half of 186 studies reached it within 21 months; a quarter within 7 and three quarters within 40.
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Studies of the drug tested here: Ibuprofen
Armed Forces Institute of Dentistry, Pakistan