Trial Outcomes & Findings for Effect of Cryotherapy on Post-endodontic Pain (NCT NCT05722704)
NCT ID: NCT05722704
Last Updated: 2024-12-24
Results Overview
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
6 hours
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
Cryotherapy
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction
|
Occlusal Reduction
Normal room temperature saline irrigation protocol with occlusal reduction
Occlusal reduction: Reduction of the functional and non-functional cusps
|
Control
Normal room temperature saline irrigation protocol without occlusal reduction
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Cryotherapy on Post-endodontic Pain
Baseline characteristics by cohort
| Measure |
Cryotherapy
n=20 Participants
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction
|
Occlusal Reduction
n=20 Participants
Normal room temperature saline irrigation protocol with occlusal reduction
Occlusal reduction: Reduction of the functional and non-functional cusps
|
Control
n=20 Participants
Normal room temperature saline irrigation protocol without occlusal reduction
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
31.4 years
STANDARD_DEVIATION 6.56 • n=7 Participants
|
32.35 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Region of Enrollment
United Arab Emirates
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 hoursEvaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Outcome measures
| Measure |
Cryotherapy
n=20 Participants
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction
|
Occlusal Reduction
n=20 Participants
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be
|
Saline
n=20 Participants
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
|
|---|---|---|---|
|
The Level of Post-endodontic Pain
|
1.85 score on a scale
Standard Deviation 1.81
|
2.15 score on a scale
Standard Deviation 2.11
|
3.65 score on a scale
Standard Deviation 3.03
|
PRIMARY outcome
Timeframe: 24 hoursEvaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Outcome measures
| Measure |
Cryotherapy
n=20 Participants
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction
|
Occlusal Reduction
n=20 Participants
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be
|
Saline
n=20 Participants
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
|
|---|---|---|---|
|
The Level of Post-endodontic Pain
|
0.70 score on a scale
Standard Deviation 1.13
|
1.2 score on a scale
Standard Deviation 1.32
|
2.2 score on a scale
Standard Deviation 1.82
|
PRIMARY outcome
Timeframe: 48 hoursEvaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Outcome measures
| Measure |
Cryotherapy
n=20 Participants
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction
|
Occlusal Reduction
n=20 Participants
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be
|
Saline
n=20 Participants
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
|
|---|---|---|---|
|
The Level of Post-endodontic Pain
|
0.25 score on a scale
Standard Deviation 0.79
|
1.2 score on a scale
Standard Deviation 1.32
|
2.2 score on a scale
Standard Deviation 1.82
|
PRIMARY outcome
Timeframe: 72 hoursEvaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Outcome measures
| Measure |
Cryotherapy
n=20 Participants
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction
|
Occlusal Reduction
n=20 Participants
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be
|
Saline
n=20 Participants
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
|
|---|---|---|---|
|
The Level of Post-endodontic Pain
|
0.10 score on a scale
Standard Error 0.45
|
0.05 score on a scale
Standard Error 0.22
|
0.25 score on a scale
Standard Error 0.72
|
Adverse Events
Cryotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Occlusal Reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place