Trial Outcomes & Findings for Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems (NCT NCT02621034)

NCT ID: NCT02621034

Last Updated: 2016-06-06

Results Overview

The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2016-06-06

Participant Flow

Participant milestones

Measure	k File hand instrumentation k file: hand instrumentation	Reciproc rotary reciprocating protocol Reciproc: reciprocating rotary instrument	One Shape one shape continuous rotation protocol One shape: full rotation protocol
Overall Study STARTED	53	52	55
Overall Study COMPLETED	50	50	50
Overall Study NOT COMPLETED	3	2	5

Reasons for withdrawal

Measure	k File hand instrumentation k file: hand instrumentation	Reciproc rotary reciprocating protocol Reciproc: reciprocating rotary instrument	One Shape one shape continuous rotation protocol One shape: full rotation protocol
Overall Study Lost to Follow-up	3	2	5

Baseline Characteristics

Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems

Baseline characteristics by cohort

Measure	Control n=50 Participants K-file hand instrumentation Control: K-file hand instrumentation	Reciproc n=50 Participants rotary reciprocating protocol Reciproc: reciprocating rotary instrument	One Shape n=50 Participants one shape continuous rotation protocol One shape: full rotation protocol	Total n=150 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 13.4 • n=5 Participants	33.2 years STANDARD_DEVIATION 13.7 • n=7 Participants	30.2 years STANDARD_DEVIATION 10.1 • n=5 Participants	31.7 years STANDARD_DEVIATION 12.3 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	31 Participants n=7 Participants	34 Participants n=5 Participants	92 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	19 Participants n=7 Participants	16 Participants n=5 Participants	58 Participants n=4 Participants
Tooth type Maxillary molars	25 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants	56 participants n=4 Participants
Tooth type Mandibular molars	25 participants n=5 Participants	39 participants n=7 Participants	30 participants n=5 Participants	94 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 hours

The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).

Outcome measures

Measure	Control n=50 Participants K-file hand instrumentation Control: K-file hand instrumentation	Reciproc n=50 Participants rotary reciprocating protocol Reciproc: reciprocating rotary instrument	One Shape n=50 Participants one shape continuous rotation protocol One shape: full rotation protocol
Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval	5 units on a scale Standard Deviation 2.8	3.2 units on a scale Standard Deviation 3.1	3.5 units on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Control n=50 Participants K-file hand instrumentation Control: K-file hand instrumentation	Reciproc n=50 Participants rotary reciprocating protocol Reciproc: reciprocating rotary instrument	One Shape one shape continuous rotation protocol One shape: full rotation protocol
Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals	0.46 units on a scale Standard Deviation 0.26	0.34 units on a scale Standard Deviation 0.15	—

PRIMARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Control n=50 Participants K-file hand instrumentation Control: K-file hand instrumentation	Reciproc n=50 Participants rotary reciprocating protocol Reciproc: reciprocating rotary instrument	One Shape n=50 Participants one shape continuous rotation protocol One shape: full rotation protocol
Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval	0.72 units on a scale Standard Deviation 0.19	0.46 units on a scale Standard Deviation 0.26	0.34 units on a scale Standard Deviation 0.15

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reciproc

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

One Shape

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

Seyed Roholla Havaei

Zahedan university of medical sciences

Phone: +989215257093

Email: marty_zl@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place