Post-endodontic Pain Survey

NCT ID: NCT04462731

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Non-surgical root canal treatment filled with WVT

Intervention Type: 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: 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.

Group Type: ACTIVE_COMPARATOR

Non-surgical root canal treatment filled with SBT

Intervention Type: 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.

Interventions

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.

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ya-Hsin Yu, DDS, MS

OTHER

Sponsor Role: lead

Responsible Party

Ya-Hsin Yu, DDS, MS

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 33555456 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

825494

Identifier Type: -

Identifier Source: org_study_id