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

Primary Purpose

Endodontically-Treated Teeth

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Root canal obturation with iRoot SP sealer

Root canal obturation with AH Plus Sealer

About this trial

This is an interventional treatment trial for Endodontically-Treated Teeth focused on measuring Endodontic Postoperative Pain, iRoot SP Sealer, Randomized Clinical Trial, Herofill carrier-based obturation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

pain iRoot SP sealer Vital Pulp

pain iRoot SP sealer Devital pulp

pain AHPlus Vital pulp

pain AHPlus Devital Pulp

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

The incidence of postoperative pain by using VAS scale after obturation with different sealers.

Secondary Outcome Measures

Full Information

NCT ID

NCT03029520

First Posted

January 11, 2017

Last Updated

January 24, 2017

Sponsor

Cukurova University

1. Study Identification

Unique Protocol Identification Number

NCT03029520

Brief Title

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

Official Title

Termoplastik Kor tekniğini Iki farklı Kanal patı Ile kullanıp Tedavi sonrası Hassasiyet ve kök Ucundan taşma miktarının değerlendirilmesi: Randomize kontrollü Klinik çalışma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cukurova University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endodontically-Treated Teeth

Keywords

Endodontic Postoperative Pain, iRoot SP Sealer, Randomized Clinical Trial, Herofill carrier-based obturation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pain iRoot SP sealer Vital Pulp

Arm Type

Active Comparator

Arm Description

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.

Arm Title

pain iRoot SP sealer Devital pulp

Arm Type

Active Comparator

Arm Description

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.

Arm Title

pain AHPlus Vital pulp

Arm Type

Active Comparator

Arm Description

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.

Arm Title

pain AHPlus Devital Pulp

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Root canal obturation with iRoot SP sealer

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Root canal obturation with AH Plus Sealer

Intervention Description

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

Primary Outcome Measure Information:

Title

The incidence of postoperative pain by using VAS scale after obturation with different sealers.

Time Frame

72 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

oguz yoldas, professor

Organizational Affiliation

vice dean

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The study will be shared at Turkish Council of Higher education thesis center

Learn more about this trial

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

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