Trial Outcomes & Findings for Post-endodontic Pain Survey (NCT NCT04462731)
NCT ID: NCT04462731
Last Updated: 2020-10-01
Results Overview
Patients were asked to rate the intensity of preoperative pain on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain ever) before receiving root canal treatment. At the end of the visit, the patients were given a survey and asked to rate the intensity of postoperative pain (VAS 0-10) at 4 hours, 24 hours, and 48 hours after the procedure.
COMPLETED
NA
194 participants
4-, 24-, and 48-hour after receiving root canal treatment
2020-10-01
Participant Flow
Only recruited irreversible pulpitis cases that received single-visit root canal treatment.
Participant milestones
| Measure |
Obturation Technique: WVT
Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
|
Obturation Technique: SBT
Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
97
|
|
Overall Study
COMPLETED
|
41
|
51
|
|
Overall Study
NOT COMPLETED
|
56
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Obturation Technique: WVT
n=41 Participants
Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
|
Obturation Technique: SBT
n=51 Participants
Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 14.4 • n=41 Participants
|
46.7 years
STANDARD_DEVIATION 16.6 • n=51 Participants
|
46.5 years
STANDARD_DEVIATION 15.6 • n=92 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=41 Participants
|
34 Participants
n=51 Participants
|
64 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=41 Participants
|
17 Participants
n=51 Participants
|
28 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 4-, 24-, and 48-hour after receiving root canal treatmentPopulation: The data from all 92 survey was included for analysis.
Patients were asked to rate the intensity of preoperative pain on a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain ever) before receiving root canal treatment. At the end of the visit, the patients were given a survey and asked to rate the intensity of postoperative pain (VAS 0-10) at 4 hours, 24 hours, and 48 hours after the procedure.
Outcome measures
| Measure |
Obturation Technique: WVT
n=41 Participants
Warm vertical compaction technique (WVT): Teeth filled with AH Plus Jet Root Canal Sealer were filled with .04 taper gutta-percha points by WVT. The sealer was introduced with the master cone. The depth of heated plugger was within 3-5 mm of WL in the WVT group, and the remaining canal space was backfilled with additional sealer and thermoplasticized gutta-percha.
|
Obturation Technique: SBT
n=51 Participants
Sealer-based filling technique (SBT): Teeth filled with SBT were obturated with EndoSequence BC Sealer by injecting the sealer into the coronal third of each canal. Size 30 Lentulo spiral coated with additional sealer was introduced 3 mm short of WL depth at 300rpm. Bioceramic coated gutta-percha was dipped in BC sealer and introduced into the canal to WL. A heated plugger was used to sear the gutta-percha point at each orifice.
|
|---|---|---|
|
Visual Analogue Scale (VAS)
Preoperative
|
4.06 score on a scale
Interval 2.95 to 5.17
|
2.68 score on a scale
Interval 1.9 to 3.45
|
|
Visual Analogue Scale (VAS)
Postoperative 4-hour
|
2.41 score on a scale
Interval 1.74 to 3.09
|
2.27 score on a scale
Interval 1.65 to 2.94
|
|
Visual Analogue Scale (VAS)
Postoperative 24-hour
|
1.95 score on a scale
Interval 1.27 to 2.63
|
1.8 score on a scale
Interval 1.14 to 2.49
|
|
Visual Analogue Scale (VAS)
Postoperative 48-hour
|
1.15 score on a scale
Interval 0.6 to 1.7
|
1.00 score on a scale
Interval 0.54 to 1.46
|
Adverse Events
Obturation Technique: WVT
Obturation Technique: SBT
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