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Post-endodontic Pain Survey

Postoperative Pain After One-visit Root Canal Treatment on Teeth With Vital Pulps: Comparison of Two Different Root Filling Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04462731
Enrollment
194
Registered
2020-07-08
Start date
2016-11-30
Completion date
2018-05-31
Last updated
2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontic Disease, Obturation, Postoperative Pain

Keywords

Postoperative Pain, Bioceramic, Root canal filling

Brief summary

As part of root canal treatment, canals should be sealed to prevent further contaminations. There are multiple accepted techniques to fill-obturate canals. In the past, different obturation techniques have been compared. The most current technique used, a single cone with bioceramic sealer, has not been compared. This clinical investigation will compare the postoperative pain of this technique to another common technique used in our clinic. Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: Comparison of three different obturation techniques.

Interventions

PROCEDURENon-surgical root canal treatment filled with WVT

All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. WVT was used to fill the tooth when the months were January, March, May, July, September, and November.

PROCEDURENon-surgical root canal treatment filled with SBT

All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. SBT was used to fill the tooth when the months were February, April, June, August, October, and December.

Sponsors

Ya-Hsin Yu, DDS, MS
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Non-surgical root canal treatment: All teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% NaOCl was used as the main irrigant. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% NaOCl and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of asymptomatic or symptomatic irreversible pulpitis according to AAE consensus. The diagnosis was based on clinical examinations and confirmed upon accessing the teeth. * Consenting adults age 18 years and older * Non-contributory medical history (ASA Class I & II) * Included patients were given oral and written information agreed for participation and signed the informed consent

Exclusion criteria

* Non-consenting patients and patients below 18 years of age * Medical history with ASA Class III & IV * Non-restorable teeth * Teeth with a non-vital pulp * Periodontal probing depths were more than 4mm * Pre-medication with antibiotics and/or analgesics 24 hours before the treatment * Patients taking analgesics routinely for non-dental reasons

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS)4-, 24-, and 48-hour after receiving root canal treatmentPatients 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.

Participant flow

Pre-assignment details

Only recruited irreversible pulpitis cases that received single-visit root canal treatment.

Participants by arm

ArmCount
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.
41
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.
51
Total92

Baseline characteristics

CharacteristicObturation Technique: WVTObturation Technique: SBTTotal
Age, Continuous46.2 years
STANDARD_DEVIATION 14.4
46.7 years
STANDARD_DEVIATION 16.6
46.5 years
STANDARD_DEVIATION 15.6
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
30 Participants34 Participants64 Participants
Sex: Female, Male
Male
11 Participants17 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 51
other
Total, other adverse events
0 / 410 / 51
serious
Total, serious adverse events
0 / 410 / 51

Outcome results

Primary

Visual Analogue Scale (VAS)

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.

Time frame: 4-, 24-, and 48-hour after receiving root canal treatment

Population: The data from all 92 survey was included for analysis.

ArmMeasureGroupValue (MEAN)
Obturation Technique: WVTVisual Analogue Scale (VAS)Preoperative4.06 score on a scale
Obturation Technique: WVTVisual Analogue Scale (VAS)Postoperative 4-hour2.41 score on a scale
Obturation Technique: WVTVisual Analogue Scale (VAS)Postoperative 24-hour1.95 score on a scale
Obturation Technique: WVTVisual Analogue Scale (VAS)Postoperative 48-hour1.15 score on a scale
Obturation Technique: SBTVisual Analogue Scale (VAS)Postoperative 48-hour1.00 score on a scale
Obturation Technique: SBTVisual Analogue Scale (VAS)Preoperative2.68 score on a scale
Obturation Technique: SBTVisual Analogue Scale (VAS)Postoperative 24-hour1.8 score on a scale
Obturation Technique: SBTVisual Analogue Scale (VAS)Postoperative 4-hour2.27 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026