NCT06795282

Brief Summary

The aim of this study was to investigate the difference in postoperative pain caused by different root canal sealers in patients with irreversible pulpitis symptoms and no apical lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 22, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

December 22, 2024

Last Update Submit

December 27, 2025

Conditions

Keywords

MTAPost-op painEpoxy resin sealerputty MTA

Outcome Measures

Primary Outcomes (1)

  • 7-day postoperative pain after root canal treatment

    At the end of the visit, patients were educated to record their postoperative pain level by assigning a number between 0 and 10 using the numerical rating scale (NRS) chart. They were categorized into four: 0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain. The patients were asked to record their pain level preoperatively, at 6, 12, and 24 h, and daily for up to 7 days, and return it to he investigators at a specific time.

    7 days

Study Arms (3)

powder-liquid MTA

The root canal will be filled with MTA at the end of the first session and patients will fill out a post-op pain form for 1 week.

Drug: MTA

Putty MTA

The root canal will be filled with putty MTA at the end of the first session and patients will fill out a post-op pain form for 1 week.

Drug: MTA

Epoxy resin sealer

The root canal will be filled with epoxy resin sealer and gutta-percha at the end of the first session and patients will fill out a post-op pain form for 1 week.

Interventions

MTADRUG

MTA is primarily composed of tricalcium silicate, dicalcium silicate, bismuth oxide (for radiopacity), and small amounts of calcium sulfate. MTA is highly biocompatible, making it suitable for use in the root canal system and areas in close contact with tissues.

Putty MTApowder-liquid MTA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Systemically healthy patients between the ages of 18-65

You may qualify if:

  • asymptomatic tooth with delayed positive response to thermal tests and electric pulp tests
  • large pulp perforation during caries removal,
  • inflamed pulp in which bleeding could not be controlled within 5 min,
  • periodontally healthy mature mandibular first or second molar tooth.

You may not qualify if:

  • patients if they were diabetic, immunocompromised, pregnant,
  • had a positive history of antibiotic use during the past 1 month,
  • required antibiotic prophylaxis
  • used analgesic within 7 days prior to the beginning of treatment,
  • were allergic to the materials used during root canal treatment,
  • if the bleeding could be controlled within 5 min and vital pulp treatment could be performed,
  • the tooth had negative response to vitality tests and/or was symptomatic,
  • had an associated periapical lesion visible on a radiograph,
  • needed a post-core or was planned to serve as prosthetic support,
  • had a calcified root canal and internal or external root resorption,
  • had tooth with open apex
  • mandibular third molars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Dentistry

Kayseri, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Pulp DiseasesTooth, NonvitalPain, Postoperative

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 28, 2025

Study Start

January 30, 2025

Primary Completion

December 1, 2025

Study Completion

December 15, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations