NCT06553144

Brief Summary

As a result of tooth decay, lesions caused by infection occur at the root tip. These teeth can heal with root canal treatment. In this study, additional applications will be made to increase the success of root canal treatment. The materials we will use are harmless. At the end of the procedure, your teeth will be monitored regularly and their healing status will be checked.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

February 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

August 10, 2024

Last Update Submit

August 13, 2024

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (2)

  • healing of periapical lesions by radiography

    The area of lesions in periapical radiographs, captured using the parallel technique, was calculated in mm² utilizing Image J 1.28 software (Figure 7) (National Institute of Health, USA).

    long-term follow-up evaluation in 12 months

  • post-op pain

    Participants were scheduled for follow-up appointments at 6, 12, and 24 hours, as well as at 1 week, during which they were asked to report any pain experienced. Pain levels were assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (most severe pain), and recorded accordingly.

    Participants were scheduled for follow-up appointments at 6, 12, and 24 hours, as well as at 1 week,

Study Arms (4)

Curcumin

EXPERIMENTAL

patient with single root and canal, along with apical radiolucent lesions

Procedure: curcumin

Erythrosine B

EXPERIMENTAL

patient with single root and canal, along with apical radiolucent lesions

Procedure: erythrosine b

Control

ACTIVE COMPARATOR

patient with single root and canal, along with apical radiolucent lesions

Procedure: control

Methylene Blue

EXPERIMENTAL

patient with single root and canal, along with apical radiolucent lesions

Procedure: methylene blue

Interventions

controlPROCEDURE

Canals were irrigated with only10 mL of 5% NaOCl

Control
methylene bluePROCEDURE

0.1 mg/mL methylene blue solition delivered into the canal and irradiated with a 100mW diode laser at a wavelength of 660 nm

Methylene Blue
erythrosine bPROCEDURE

0.3 mg/mL eryrhtosine b solition delivered into the canal and irradiated with a 100mW diode laser at a wavelength of 660 nm

Erythrosine B
curcuminPROCEDURE

5.0 mg/mL curcumin solition delivered into the canal and irradiated with a 200mW diode laser at a wavelength of 450 nm

Curcumin

Eligibility Criteria

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

You may qualify if:

  • Encompassed lower premolars
  • Upper central and lateral incisors with a single root and canal, along with apical radiolucent lesions

You may not qualify if:

  • Periodontal pockets exceeding 4 mm,
  • Mobility,
  • Nonrestorability,
  • Immaturity,
  • any indications of fracture or dental anomalies
  • chronic drug users

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Üniversitesi

Gaziantep, Adana, 01130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Methylene BlueErythrosineCurcumin

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoresceinsSpiro CompoundsHydrocarbons, CyclicHydrocarbonsXanthenesPolycyclic CompoundsDiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicCatecholsPhenolsBenzene DerivativesHydrocarbons, Aromatic

Study Officials

  • REYHAN ECE ARI

    University of Gaziantep

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

August 10, 2024

First Posted

August 14, 2024

Study Start

February 1, 2021

Primary Completion

November 1, 2021

Study Completion

December 12, 2021

Last Updated

August 16, 2024

Record last verified: 2024-08

Locations

TU(1)