Post-endodontic Pain Survey

NCT04462731 | Completed Results

• 1 other identifier: 825494
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain; Endodontic Disease; Obturation

Keywords

Postoperative Pain; Bioceramic; Root canal filling

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Obturation technique: WVT

EXPERIMENTAL

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

Obturation technique: SBT

ACTIVE COMPARATOR

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

Interventions

Non-surgical root canal treatment filled with WVT PROCEDURE

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.

Obturation technique: WVT

Non-surgical root canal treatment filled with SBT PROCEDURE

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.

Obturation technique: SBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ya-Hsin Yu, DDS, MS: lead

Related Publications (1)

• Yu YH, Kushnir L, Kohli M, Karabucak B. Comparing the incidence of postoperative pain after root canal filling with warm vertical obturation with resin-based sealer and sealer-based obturation with calcium silicate-based sealer: a prospective clinical trial. Clin Oral Investig. 2021 Aug;25(8):5033-5042. doi: 10.1007/s00784-021-03814-x. Epub 2021 Feb 8.

  PMID: 33555456 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Dental Pulp Diseases; Bites and Stings

Interventions

Serum Bactericidal Test

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Microbial Sensitivity Tests; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Evaluation, Preclinical; Evaluation Studies as Topic

Results Point of Contact

• Title: Ya-Hsin Yu
• Organization: University of Pennsylvania

yayu@upenn.edu

215-898-4927

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 8, 2020
• Study Start: November 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 1, 2020
• Results First Posted: July 24, 2020

Record last verified: 2020-09