NCT04228913

Brief Summary

This study evaluated the postoperative pain after the endodontic treatment by using three different obturation techniques. ( Cold lateral condensation (CLC), thermoplasticized solid-core carrier method (GuttaCore) and cold free-flow compation tecnique ( GuttaFlow2))

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

January 7, 2020

Last Update Submit

January 13, 2020

Conditions

Pain, PostoperativePainEndodontic Inflammation

Keywords

cold lateral condensationPostoperative PainGuttaCoreGuttaFlow 2Obturation Techniques

Outcome Measures

Primary Outcomes (9)

  • Pain level comparison after root canal obturation with three different obturation technique:: VAS (Visual Analogue Scale) at 6th hours.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    6th hours.

  • Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 12th hours.

    ased on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    12th hours.

  • Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 24th hours

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    24th hours.

  • Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 2nd days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    2nd days

  • Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 3th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    3th days

  • Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 4th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    4th days.

  • Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 5th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    5th days

  • Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 6th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    6th days

  • Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 7th days.

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

    7th days

Secondary Outcomes (9)

  • Analgesic intake comparison after root canal obturation with three different obturation technique at 6th hours

    6th hours.

  • Analgesic intake comparison after root canal obturation with three different obturation technique at 12th hours

    12th hours

  • Analgesic intake comparison after root canal obturation with three different obturation technique at 24th hours

    24th hours.

  • Analgesic intake comparison after root canal obturation with three different obturation technique at 2nd days

    2nd days

  • Analgesic intake comparison after root canal obturation with three different obturation technique at 3th days

    3th days

  • +4 more secondary outcomes

Study Arms (3)

Ah plus

OTHER

The root canals obturated with Ah plus root canal sealer (Dentsply, Sirona) and gutta-percha cones with cold lateral condensation technique.

Other: Root Canal Obturation Technique

ROEKO GuttaFlow® 2

OTHER

The root canals obturated with GuttaFlow 2 root canal sealer (Coltene,Whaledent) and single tapered gutta-percha cone with cold free flow compaction technique.

Other: Root Canal Obturation Technique

GuttaCore Obturators

OTHER

The root canals obturated with GuttaCore obturators (Dentsply,Sirona) and Ah plus root canal sealer with thermoplasticized solid-core carrier technique

Other: Root Canal Obturation Technique

Interventions

Root Canal Obturation TechniqueOTHER

This study aims to compare the effects of three different obturation techniques(cold lateral condensation,thermoplasticized solid-core carrier method, cold free flow compaction technique) on postoperative pain following the endodontic therapy

Ah plusGuttaCore ObturatorsROEKO GuttaFlow® 2

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Participants between 18 - 72 years of ages,
  • Good oral hygiene,
  • \. Have not taken any analgesic in the last 7 days,
  • \. Have not taken any antibiotics in the last 7 days,
  • \. Positive response to both cold test (EndoIce; Coltene/Whaledent Inc, Cuyahoga ),
  • \. Patients diagnosed with asymptomatic irreversible pulpitis with his/her single-rooted teeth caused by a deep carious lesion,
  • \. Patients have single-rooted teeth requiring endodontic treatment according to the pre-prosthetic reason,
  • The presence of profusely pulp bleeding with a thick consistency, which is exposed during caries removing.
  • \. The periapical region was healthy in radiographic diagnosis.

You may not qualify if:

  • Patients who refuse to participate in this study,
  • Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications),
  • Devital teeth that have no response to pulp test,
  • The presence of advanced periodontal disease (probing depth \> 4 mm),
  • The presence of open apex,
  • The presence of calcification,
  • The presence of resorption,
  • Patients who had multiple teeth requiring endodontic treatment,
  • Patients with allergic sensitivity to materials and agents that should be used during the root canal treatment,
  • Allergic sensitivity to local anesthetics,
  • Patients who had systemic or allergic sensitivity for the NSAIDs,
  • Pregnant participants or participants in the lactation period,
  • Teeth cannot be applied to a rubber-dam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hicran Dönmez Özkan

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (4)

  • Alonso-Ezpeleta LO, Gasco-Garcia C, Castellanos-Cosano L, Martin-Gonzalez J, Lopez-Frias FJ, Segura-Egea JJ. Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: comparison of three different obturation techniques. Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17(4):e721-7. doi: 10.4317/medoral.17898.

    PMID: 22322522BACKGROUND

  • Su Y, Wang C, Ye L. Healing rate and post-obturation pain of single- versus multiple-visit endodontic treatment for infected root canals: a systematic review. J Endod. 2011 Feb;37(2):125-32. doi: 10.1016/j.joen.2010.09.005. Epub 2010 Nov 12.

    PMID: 21238790BACKGROUND

  • Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.

    PMID: 29571915RESULT

  • Kocer A, Donmez Ozkan H, Turk T. Postoperative pain intensity and incidence following single visit root canal treatment with different obturation techniques: a randomized clinical trial. PeerJ. 2022 Jul 27;10:e13756. doi: 10.7717/peerj.13756. eCollection 2022.

    PMID: 35915749DERIVED

MeSH Terms

Conditions

Pain, PostoperativePainPulpitis

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsDental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Hicran Dönmez Özkan

    Adnan Menderes University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Single (Participant)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 14, 2020

Study Start

August 31, 2017

Primary Completion

March 4, 2019

Study Completion

August 15, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)