Trial Outcomes & Findings for Effect of Root Canal Treatment (Versus no Treatment) for Patients With Tooth Infections and Toothaches (NCT NCT01870973)

Results Overview

pain measurement as assessed on a visual analog scale and pain medication usage definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

108 participants

Primary outcome timeframe

each day for 5 days

Results posted on

2015-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Root Canal Treatment root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin) root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.	no Root Canal Treatment no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin) no root canal treatment
Overall Study STARTED	56	52
Overall Study COMPLETED	46	49
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Root Canal Treatment root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin) root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.	no Root Canal Treatment no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin) no root canal treatment
Overall Study Lost to Follow-up	10	3

Baseline Characteristics

Effect of Root Canal Treatment (Versus no Treatment) for Patients With Tooth Infections and Toothaches

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Root Canal Treatment n=46 Participants root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin) root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.	no Root Canal Treatment n=49 Participants no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin) no root canal treatment	Total n=95 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 12.1 • n=5 Participants	39.1 years STANDARD_DEVIATION 16.1 • n=7 Participants	37.7 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	49 participants n=7 Participants	95 participants n=5 Participants

PRIMARY outcome

Timeframe: each day for 5 days

pain measurement as assessed on a visual analog scale and pain medication usage definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success.

Outcome measures

Outcome measures
Measure	Root Canal Treatment n=46 Participants root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin) root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.	no Root Canal Treatment n=49 Participants no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin) no root canal treatment
Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use	52 percentage of participants	43 percentage of participants

Adverse Events

Root Canal Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Root Canal Treatment

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

Dr. Melissa Drum

The Ohio State University

Phone: 6142923596

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place