Post-Obturation Pain Following the Use of the AH Plus and iRoot SP Sealers

NCT ID: NCT03029520

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-01-31

Brief Summary

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The aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers.

In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. Patients with vital and devital teeth were assigned to four groups using a randomized block design with block sizes of 10 patients each. The groups were composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator prepared root canals and filled them with sealer using the carrier-based obturation technique. Radiographs were taken and obturation length was recorded. Patients recorded pain scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6, 6-12, 12-24, and 24-72 h..

Detailed Description

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This randomized controlled clinical study was conducted to compare the incidence and intensity of post-obturation pain, evaluate the overextension of filling material radiographically, and assess the relationship between pain and analgesic intake in patients with vital and devital teeth undergoing carrier-based obturation with two different sealers (iRoot SP, AH Plus)

Conditions

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Endodontically-Treated Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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pain iRoot SP sealer Vital Pulp

Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) vital pulp.

Group Type ACTIVE_COMPARATOR

Root canal obturation with iRoot SP sealer

Intervention Type OTHER

Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.

pain iRoot SP sealer Devital pulp

Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) devital pulp.

Group Type ACTIVE_COMPARATOR

Root canal obturation with iRoot SP sealer

Intervention Type OTHER

Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.

pain AHPlus Vital pulp

Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) vital pulp.

Group Type ACTIVE_COMPARATOR

Root canal obturation with AH Plus Sealer

Intervention Type OTHER

Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.

pain AHPlus Devital Pulp

Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) devital pulp.

Group Type ACTIVE_COMPARATOR

Root canal obturation with AH Plus Sealer

Intervention Type OTHER

Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.

Interventions

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Root canal obturation with iRoot SP sealer

Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.

Intervention Type OTHER

Root canal obturation with AH Plus Sealer

Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* no systemic diseases
* women were not pregnant or breastfeeding status
* no history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment.
* all selected teeth were mandibular molar or mandibular premolar.

Exclusion Criteria

* systemic and/or periodontal disease;
* allergy to local anesthetic agents and/or history of intolerance to nonsteroidal anti-inflammatory drugs;
* requirement for antibiotic prophylaxis
* open tooth apex
* pacemaker use
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Ayfer Atav Ateş

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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oguz yoldas, professor

Role: STUDY_CHAIR

vice dean

Other Identifiers

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BAPKOM 4949

Identifier Type: -

Identifier Source: org_study_id

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