Effect Of Simultaneous Working Length Control Postoperative Pain

NCT03899129 | Unknown

• 1 other identifier: CEBD-CU-2019-03-02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to evaluate the effect of simultaneous length control during root canal preparation on postoperative pain compared with separate working length determination and root canal preparation using electronic apex locator. During preparation of root canals, loss of working length (WL) can lead to instrumentation beyond the predefined apical limit of the preparation. This effect is mainly attributed to straightening of the root canal during instrumentation. Some studies showed, that this kind of over instrumentation as well as under instrumentation can adversely affect the outcome of the endodontic treatment, while it remains uncertain what exactly is the most favorable extent of the apical limit of root canal preparation. Furthermore, all endodontic instruments produce apical extrusion of debris, even when the preparation is kept within the confines of the root canal. Consequently, preparations ending in the periapical tissue will produce a greater amount of debris extrusion that could elicit a neurogenic inflammatory response resulting from an irritation of the periodontal ligament with subsequent postoperative symptomatic apical periodontitis. Therefore, it seems favorable to control the determined WL during root canal preparation to avoid preparations ending in the periapical tissue.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain after endodontic treatment

  Intensity of postoperative pain will be measured using Visual Analogue scale (VAS) for pain assessment 7 days after the end of endodontic treatment. It uses numerical data: None 0, Mild \<20, Moderate 20-50 and Sever \>50.

  7 days after root canal treatment.

Secondary Outcomes (1)

• Number of analgesic tablets taken by the patient after endodontic treatment.

  Until 7 days after endodontic treatment.

Study Arms (2)

simultaneous working length control

EXPERIMENTAL

• Using simultaneous working length control during root canal preparation using E-CONNECT S endomotor with integrated apex locator.

Procedure: simultaneous working length control using E-CONNECT S

Root ZX apex locator.

ACTIVE COMPARATOR

Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.

Procedure: separate length determination and root canal preparation using Root ZX apex locator.

Interventions

simultaneous working length control using E-CONNECT S PROCEDURE

E-CONNECT S (Eighteeth medical technology Co., Ltd, china) is an endomotor with integrated apex locator newly introduced in the market with continuous WL measuring function. It contains an optional module for rotary instrumentation, allowing the device to function as a low-speed handpiece, apex locator, or a combination of both. This motor has an attention-grabbing property that when an instrument reaches the predetermined working length, the motor automatically stops the instrumentation. Thus, it can be concluded that automatically stopping instrumentation when the instrument reaches the working length would decrease postoperative pain compared with manually controlling the working length by using stoppers during instrumentation (separate length determination and root canal preparation).

simultaneous working length control

separate length determination and root canal preparation using Root ZX apex locator. PROCEDURE

Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.

Root ZX apex locator.

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between (20-50) years old with symptomatic irreversible pulpitis in permanent mandibular premolar teeth.
• Systemically- healthy patients (ASA I or II).
• Patients who agree to attend for recall appointments and provide written consent.

You may not qualify if:

• Pregnant women and patients with pacemakers.
• Patients with bruxism or clenching or have taken analgesics during past 24 hours.
• Moderate or severe marginal periodontitis (i.e. pocket probing \>3 mm).
• Necrotic pulp, pulp polyp, tooth tender to percussion, preoperative palpation pain, clinical progression into periapical abscess, fistula.
• Teeth with internal or external resorption, curvatures, open apices, root canal obliteration, perforation, incomplete root formation, teeth previously undergone root canal treatment, absence of opposing tooth to the related tooth or radiographically invisible canals.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Aml M moteleb

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aml M moteleb

CONTACT

20-01092359661; aml.abdelmoteleb@dentistry.cu.edu.eg

Heba elasfouri

CONTACT

20-01005276232; Heba.elasfouri@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will be participant-blind where the participants will not know the intervention done. The applications could not be blinded; however, the statistician will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master degree student, Endodontic department

Model Details: Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: April 2, 2019
• Study Start: October 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available within 6 months from study completion
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.