An interventional study of Non-surgical root canal treatment filled with WVT and Non-surgical root canal treatment filled with SBT in Postoperative Pain, Endodontic Disease and Obturation, sponsored by Ya-Hsin Yu, DDS, MS. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Ya-Hsin Yu, DDS, MS · Not applicable, Interventional, and Treatment
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.
125 studies on the registry are indexed under Dental Pulp Diseases; 38 are open to participants now.
This study's enrollment of 194 is above the median of 50 across 103 interventional studies indexed under Dental Pulp Diseases.
Browse Dental Pulp Diseases studies →This is the only study on the registry with Ya-Hsin Yu, DDS, MS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Non-surgical root canal treatment filled with WVT
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.
Procedure: Non-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. WVT was used to fill the tooth when the months were January, March, May, July, September, and November.
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.
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
| Milestone | Obturation Technique: WVT | Obturation Technique: SBT |
|---|---|---|
| Started | 97 | 97 |
| Completed | 41 | 51 |
| Not completed | 56 | 46 |
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.
| score on a scale | Obturation Technique: WVT | Obturation Technique: SBT |
|---|---|---|
| Preoperative | 4.06 (2.95 to 5.17) | 2.68 (1.90 to 3.45) |
| Postoperative 4-hour | 2.41 (1.74 to 3.09) | 2.27 (1.65 to 2.94) |
| Postoperative 24-hour | 1.95 (1.27 to 2.63) | 1.8 (1.14 to 2.49) |
| Postoperative 48-hour | 1.15 (0.60 to 1.70) | 1.00 (0.54 to 1.46) |
Collected over 1.Preoperative 2. 4-, 24-, and 48-hour postoperatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Obturation Technique: WVT | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Obturation Technique: SBT | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(years) | Obturation Technique: WVT | Obturation Technique: SBT | Total |
|---|---|---|---|
| Mean | 46.2 ± 14.4 | 46.7 ± 16.6 | 46.5 ± 15.6 |
| Sex: Female, Male(Participants) | Obturation Technique: WVT | Obturation Technique: SBT | Total |
|---|---|---|---|
| Female | 30 | 34 | 64 |
| Male | 11 | 17 | 28 |
| Race and Ethnicity Not Collected(Participants) | Obturation Technique: WVT | Obturation Technique: SBT | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.