Trial Outcomes & Findings for Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain. (NCT NCT02907489)

Results Overview

Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a "0" at its first part and a "10" in the last part. With "0" indicating the best outcome while "10" the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain \[0\], mild pain \[1-3\], moderate pain \[4-7\] or severe pain \[8-10\] )

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

84 participants

Primary outcome timeframe

after 24, 48, and 72 hour from the end of the first visit.

Results posted on

2019-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Control: Calcium Hydroxide Non-setting Calcium Hydroxide	Test: Triple Antibiotic Paste and Anti-Inflammatory Drug Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
Overall Study STARTED	42	42
Overall Study COMPLETED	40	41
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control: Calcium Hydroxide n=42 Participants non setting calcium hydroxide	Test: Triple Antibiotic Paste and Anti-Inflammatory Drug n=42 Participants Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)	Total n=84 Participants Total of all reporting groups
Age, Continuous	32.23 years STANDARD_DEVIATION 9.75 • n=42 Participants	32.32 years STANDARD_DEVIATION 9.65 • n=42 Participants	32.28 years STANDARD_DEVIATION 9.7 • n=84 Participants
Sex: Female, Male Female	16 Participants n=42 Participants	22 Participants n=42 Participants	38 Participants n=84 Participants
Sex: Female, Male Male	26 Participants n=42 Participants	20 Participants n=42 Participants	46 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: after 24, 48, and 72 hour from the end of the first visit.

Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a "0" at its first part and a "10" in the last part. With "0" indicating the best outcome while "10" the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain \[0\], mild pain \[1-3\], moderate pain \[4-7\] or severe pain \[8-10\] )

Outcome measures

Outcome measures
Measure	Control: Calcium Hydroxide n=40 Participants non setting calcium hydroxide	Test: Triple Antibiotic Paste and Anti-Inflammatory Drug n=41 Participants Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
Post Operative Pain 24 hrs	3.18 score on a scale Standard Deviation 2.37	2.27 score on a scale Standard Deviation 2.28
Post Operative Pain 48 hrs	2.20 score on a scale Standard Deviation 2.00	1.39 score on a scale Standard Deviation 1.46
Post Operative Pain 72 hrs	1.30 score on a scale Standard Deviation 1.36	0.78 score on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.

Colony forming units per milliliter of blood agar medium before root canal preparation (S1), after root canal preparation (S2) and after intracanal medication application for 72 hours (S3)

Outcome measures

Outcome measures
Measure	Control: Calcium Hydroxide n=40 Participants non setting calcium hydroxide	Test: Triple Antibiotic Paste and Anti-Inflammatory Drug n=41 Participants Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
Intracanal Bacterial Count S1	3.84 CFU/ml Standard Deviation 1.70	3.85 CFU/ml Standard Deviation 2.01
Intracanal Bacterial Count S2	3.63 CFU/ml Standard Deviation 1.63	3.36 CFU/ml Standard Deviation 1.74
Intracanal Bacterial Count S3	2.14 CFU/ml Standard Deviation 1.36	1.33 CFU/ml Standard Deviation 1.39

Adverse Events

Control: Calcium Hydroxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test: Triple Antibiotic Paste and Anti-Inflammatory Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mohamed Omaia Ahmed

Cairo university

Phone: 00201224474609

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place