Trial Outcomes & Findings for Efficacy of Different Drugs to Control Post Root Canal Treatment Pain (NCT NCT02417337)

Results Overview

Pain was recorded in the verbal rating scale-4 (VRS-4 scale) before and after 8 hours of medication. The VRS-4 Scale has four categories of pain scores: no pain is the minimum (better outcome), slight pain, moderate pain, and severe pain score is the maximum (worse outcome).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

185 participants

Primary outcome timeframe

8 hours

Results posted on

2026-08-10

Participant Flow

The sample was made up of patients attending the clinics of the Faculty of Dentistry, University of Khartoum and the Khartoum Teaching Hospital emergency clinic, which were the setting and location of the trial. The clinical trial dates of recruitment was between August 2012 and August 2014.

Participant milestones

Participant milestones
Measure	Group I paracetamol 1000mg Paracetamol: NSAID	Group II ibuprofen 600mg + paracetamol 1000mg, Paracetamol: NSAID Ibuprofen: NSAID	Group III Mefenamic acid 500mg + Paracetamol 1000mg Paracetamol: NSAID Mefenamic Acid: NSAID	Group IV Diclofenac K 50mg + paracetamol 1000 mg Paracetamol: NSAID Diclofenac: NSAID	Group V Placebo/No medication
Overall Study STARTED	37	37	37	37	37
Overall Study COMPLETED	34	33	34	35	34
Overall Study NOT COMPLETED	3	4	3	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Group I paracetamol 1000mg Paracetamol: NSAID	Group II ibuprofen 600mg + paracetamol 1000mg, Paracetamol: NSAID Ibuprofen: NSAID	Group III Mefenamic acid 500mg + Paracetamol 1000mg Paracetamol: NSAID Mefenamic Acid: NSAID	Group IV Diclofenac K 50mg + paracetamol 1000 mg Paracetamol: NSAID Diclofenac: NSAID	Group V Placebo/No medication
Overall Study Withdrawal by Subject	2	1	2	2	0
Overall Study Lost to Follow-up	1	3	1	0	3

Baseline Characteristics

15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group I n=34 Participants paracetamol 1000mg Root Canal Treatment: A standardized endodontic procedures performed. Paracetamol	Group II n=33 Participants ibuprofen 600mg + paracetamol 1000mg, Root Canal Treatment: A standardized endodontic procedures performed. Paracetamol Ibuprofen	Group III n=34 Participants Mefenamic acid 500mg + Paracetamol 1000mg Root Canal Treatment: A standardized endodontic procedures performed. Paracetamol Mefenamic acid	Group IV n=35 Participants Diclofenac K 50mg + paracetamol 1000 mg Root Canal Treatment: A standardized endodontic procedures performed. Paracetamol Diclofenac	Group V n=34 Participants No medication Root Canal Treatment: A standardized endodontic procedures performed.	Total n=170 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=54 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=54 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=27 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=26 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=161 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=120 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).
Age, Categorical Between 18 and 65 years	34 Participants n=54 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	33 Participants n=54 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	34 Participants n=27 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	35 Participants n=26 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	34 Participants n=161 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	170 Participants n=120 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).
Age, Categorical >=65 years	0 Participants n=54 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=54 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=27 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=26 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=161 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).	0 Participants n=120 Participants • 15 participants were lost in this study. 7 withdrew and 8 lost to follow (medications fallen on the ground and were considered damaged, because of cross-infection).
Age, Continuous	31.12 years STANDARD_DEVIATION 8.92 • n=54 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	43.12 years STANDARD_DEVIATION 9.96 • n=54 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	33.97 years STANDARD_DEVIATION 11.62 • n=27 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	32.97 years STANDARD_DEVIATION 11.43 • n=26 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	32.38 years STANDARD_DEVIATION 10.47 • n=161 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	33 years STANDARD_DEVIATION 10.5 • n=120 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.
Sex: Female, Male Female	19 Participants n=54 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	23 Participants n=54 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	24 Participants n=27 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	21 Participants n=26 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	17 Participants n=161 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	104 Participants n=120 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.
Sex: Female, Male Male	15 Participants n=54 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	10 Participants n=54 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	10 Participants n=27 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	14 Participants n=26 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	17 Participants n=161 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	66 Participants n=120 Participants • 8 particpants had their medications fall on the gound during taking the medication, consdered damaged (becuase of cross infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.
Region of Enrollment Sudan	34 participants n=54 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	33 participants n=54 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	34 participants n=27 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	35 participants n=26 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	34 participants n=161 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.	170 participants n=120 Participants • 8 participants had their medications fall on the ground during taking the medication, considered damaged (because of cross-infection) and excluded. They were given another chance to draw another sachet from the dark bag. 7 were lost during the investigation, either not returning to complete treatment or not answering phone calls.

PRIMARY outcome

Timeframe: 8 hours

Pain was recorded in the verbal rating scale-4 (VRS-4 scale) before and after 8 hours of medication. The VRS-4 Scale has four categories of pain scores: no pain is the minimum (better outcome), slight pain, moderate pain, and severe pain score is the maximum (worse outcome).

Outcome measures

Outcome measures
Measure	Group I n=34 Participants paracetamol 1000mg Paracetamol: NSAID	Group II n=33 Participants ibuprofen 600mg + paracetamol 1000mg, Paracetamol: NSAID Ibuprofen: NSAID	Group III n=34 Participants Mefenamic acid 500mg + Paracetamol 1000mg Paracetamol: NSAID Mefenamic Acid: NSAID	Group IV n=35 Participants Diclofenac K 50mg + paracetamol 1000 mg Paracetamol: NSAID Diclofenac: NSAID	Group V n=34 Participants Placebo, no medication Placebo: empty double gelatinous capsules, having similar weight and appearance of the medications
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale Pain Scores before treatment per Group on the VRS-4 Scale · slight pain	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale Pain Scores before treatment per Group on the VRS-4 Scale · moderate pain	12 Participants	8 Participants	7 Participants	15 Participants	12 Participants
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale Pain Scores before treatment per Group on the VRS-4 Scale · no pain	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale Pain Scores before treatment per Group on the VRS-4 Scale · severe pain	22 Participants	25 Participants	27 Participants	20 Participants	22 Participants
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale 8 hours after treatment per Group on the VRS-4 Scale · no pain	13 Participants	23 Participants	21 Participants	20 Participants	14 Participants
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale 8 hours after treatment per Group on the VRS-4 Scale · slight pain	8 Participants	3 Participants	4 Participants	10 Participants	7 Participants
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale 8 hours after treatment per Group on the VRS-4 Scale · moderate pain	4 Participants	4 Participants	7 Participants	1 Participants	6 Participants
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale 8 hours after treatment per Group on the VRS-4 Scale · severe pain	9 Participants	3 Participants	2 Participants	4 Participants	7 Participants

PRIMARY outcome

Timeframe: 8 hours

(NRS-11) numerical rating scale of pain between 0 (better) and 10 (worse) before and after treatment

Outcome measures

Outcome measures
Measure	Group I n=34 Participants paracetamol 1000mg Paracetamol: NSAID	Group II n=33 Participants ibuprofen 600mg + paracetamol 1000mg, Paracetamol: NSAID Ibuprofen: NSAID	Group III n=34 Participants Mefenamic acid 500mg + Paracetamol 1000mg Paracetamol: NSAID Mefenamic Acid: NSAID	Group IV n=35 Participants Diclofenac K 50mg + paracetamol 1000 mg Paracetamol: NSAID Diclofenac: NSAID	Group V n=34 Participants Placebo, no medication Placebo: empty double gelatinous capsules, having similar weight and appearance of the medications
Pain Score on Numerical Rating Scale of Pain (NRS-11) before treatment	8 score on a scale Interval 0.0 to 10.0	8 score on a scale Interval 0.0 to 10.0	8 score on a scale Interval 0.0 to 10.0	8 score on a scale Interval 0.0 to 10.0	8 score on a scale Interval 0.0 to 10.0
Pain Score on Numerical Rating Scale of Pain (NRS-11) after treatment	2.25 score on a scale Interval 0.0 to 10.0	0.17 score on a scale Interval 0.0 to 10.0	1.0 score on a scale Interval 0.0 to 10.0	0.5 score on a scale Interval 0.0 to 10.0	2.82 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 8 hours

Population: every group is analysed by male or female and maxillary or mandibular teeth before treatment and after 8 hours

Numerical rating scale (NRS-11), (0 better/the least pain score to 10 worse/the maximum pain score), , was done for sex (male or female) and jaw type (maxilla or mandible)