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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04462731
Other study ID # 825494
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date May 2018

Study information

Verified date September 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 194
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Non-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.
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. SBT was used to fill the tooth when the months were February, April, June, August, October, and December.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ya-Hsin Yu, DDS, MS

Outcome

Type Measure Description Time frame Safety issue
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. 4-, 24-, and 48-hour after receiving root canal treatment
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