Patient intraoperative discomfort after using rotary or reciprocating systems

• Register: ISRCTN
• Last refreshed on: 29 November 2021
• Main ID: ISRCTN11624674
• Date of registration: 14/04/2016
• Prospective Registration: No
• Primary sponsor: National Council for Scientific and Technological Development (Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq)
• Public title: Patient intraoperative discomfort after using rotary or reciprocating systems
• Scientific title: Patient intraoperative discomfort after using rotary or reciprocating systems: a prospective and randomized clinical trial
• Date of first enrolment: 01/01/2015
• Target sample size: 23
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11624674
• Study type: Interventional
• Study design: Randomized clinical trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Brazil

Contacts

• Name: Emmanuel Silva

Key inclusion & exclusion criteria

Inclusion criteria:
1. Healthy (ASA I) adults older than 18 years of age that had been admitted to the Endodontics Department of FOP-UNICAMP, from January 2015 to December 2015 with a clinical diagnosis of irreversible pulpitis or necrosis in the first or second maxillary and mandibular molars
2. Pulpal status that has been confirmed by a cold test

Exclusion criteria:
1. Taking any medication that could alter their perception of pain (analgesic or non steroidal anti-inflammatory drugs)
2. Radiographic findings that included absence of periapical radiolucency except for a widened periodontal ligament


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Endodontic disease
Oral Health

Intervention(s)

After local anesthesia with 2% lidocaine with 1:100,000 epinephrine, a rubber dam was placed and the access cavity was prepared using sterile diamond burs. If patients recorded any pain sensation during the procedure, supplemental injection of local infiltration with 1.8 mL 2% lidocaine with 1:100.000 epinephrine was administered.

An initial exploration of the root canals was performed with size 10-K files (VDW), to establish the root canal length using an electronic apex locator (Root ZX II; J. Morita Corp., Tokyo, Japan). Working length (WL) was established by deducting 1 mm from the canal length. Only cases where a 10-K file go passively and a 15-K file did not got passively to the WL in both canals (mesiobuccal and distobuccal canals for maxillary molars; mesiobuccal and mesiolingual canals for mandibular molars) were selected. These cases were classified as small and R25 was recommended, according to the manufacturer´s protocol. All teeth received the two different instrumentation protocols (Mtwo rotary system or Reciproc reciprocation system). A web-based program determined randomized allocation of the instrumentation systems per canal. While the endodontist were not blinded to the allocated file system, patients were kept blinded to the allocation. Instruments were driven with the VDW Silver motor (VDW) according to each manufacturer`s instructions:

1. Reciproc R25 (25/0.08) was introduced into the canal until resistance was felt and then activated in reciprocating motion. The instrument was moved in an apical direction using an in-and-out pecking motion of about 3 mm in amplitude with a light apical pressure. After 3 pecking motions, the instrument was removed from the canal, and its flutes were cleaned off. Thi

Primary Outcome(s)

Intraoperative discomfort, measured using the visual analogue score (VAS), during the procedure, between the two different instrumentation groups

Secondary ID(s)

058/2015

Source(s) of Monetary Support

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Results

• Results available: Yes
• Date Completed: 31/12/2015