NCT03919318

Brief Summary

This study evaluated the postoperative pain after the endodontic treatment using AH Plus, Endoseal MTA and EndoSequence BC sealers in root canal obturation.

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 not_applicable postoperative-pain

Timeline
Completed

Started Apr 2018

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

April 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

April 14, 2019

Last Update Submit

November 30, 2019

Conditions

Postoperative Pain

Keywords

postoperative painEndoseal MTAEndosequence BCAH PlusRoot canal fillingendodontic treatment

Outcome Measures

Primary Outcomes (9)

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

    12th hours

  • Pain level comparison after root canal obturation with three different endodontic sealers: 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 endodontic sealers: VAS (Visual Analogue Scale) at 48th 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.

    48th hours

  • Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 3rd 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.

    3rd days

  • Pain level comparison after root canal obturation with three different endodontic sealers: 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 endodontic sealers: 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 endodontic sealers: 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 endodontic sealers: 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 endodontic sealers at 6th hours.

    6th hours

  • Analgesic intake comparison after root canal obturation with three different endodontic sealers at 12th hours.

    12th hours

  • Analgesic intake comparison after root canal obturation with three different endodontic sealers at 24th hours.

    24th hours

  • Analgesic intake comparison after root canal obturation with three different endodontic sealers at 48th hours.

    48th hours

  • Analgesic intake comparison after root canal obturation with three different endodontic sealers at 3rd days.

    3rd days

  • +4 more secondary outcomes

Study Arms (3)

AH-Plus

EXPERIMENTAL
Other: Root Canal Filling Sealers

EndoSeal MTA

EXPERIMENTAL
Other: Root Canal Filling Sealers

Endosequence BC Sealer

EXPERIMENTAL
Other: Root Canal Filling Sealers

Interventions

Root Canal Filling SealersOTHER

Root Canal Obturation

AH-PlusEndoSeal MTAEndosequence BC Sealer

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants between 18 - 60 years of age,
  • Good oral hygiene,
  • Have not taken any analgesics in the last day,
  • Have not taken antibiotics in the last week,
  • Patients diagnosed with asymptomatic irreversible pulpitis caused by deep carious lesion on the mandibular first or second molar teeth.
  • A prolonged positive response to cold vitality tests,
  • The presence of pulp, which is exposed during caries removing and bleeding with a dense and thick consistency.
  • The periapical region was healthy in radiographic diagnosis.

You may not qualify if:

  • Devital teeth that have no response to pulp test,
  • The presence of advanced periodontal disease,
  • Having a systemic disease that requires antibiotic prophylaxis,
  • Radiographically more than 30° root inclination, presence of clear apex, presence of calcification, presence of root resorption,
  • The need for root canal treatment which is mesial and/or distal neighbour of the tooth to be treated,
  • The presence of a sinus tract in the relevant tooth region,
  • Having systemic diseases that reduce immune system resistance,
  • Participants with allergic sensitivity to materials and agents that should be used during the root canal treatment,
  • Allergic sensitivity to local anesthetics,
  • Pregnant participants or participants in the lactation period,
  • Over preparation or over filling during treatment,
  • Teeth which cannot be applied a rubber-dam,
  • Teeth which was damaged enough to require coronal fiber post application,
  • Sensitive to Ibuprofen based analgesics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University, Faculty of Dentistry

Kayseri, İç Anadolu, 38039, Turkey (Türkiye)

Location

Related Publications (2)

  • 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: 29571915BACKGROUND

  • Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.

    PMID: 30397735BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Tuğrul Aslan, PHD. Dr.

    Erciyes University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Prof.

Study Record Dates

First Submitted

April 14, 2019

First Posted

April 18, 2019

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 5, 2019

Last Updated

December 3, 2019

Record last verified: 2019-11

Locations

TU(1)