NCT04010929

Brief Summary

The aim of this study was to compare the efficacy of partial pulpotomy treatment using MTA and Er,Cr:YSGG + MTA in permanent immature molar teeth with deep dentin caries. The study was performed in children aged between 6-15 who had at least one deep dentine caries in permanent immature molar tooth. The patients' therapies were completed in Kırıkkale University, Faculty of Dentistry, Department of Pediatric Dentisry. A total of 90 teeth (caries exposed) were included in the study. According to the treatment, the teeth were randomly divided into two groups: 1. MTA group (n=45), 2. Laser+MTA group (n=45). In the MTA group, after removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl. In the same session, the tooth was restored with resin modified glass ionomer cement and composite resin. In the laser+MTA group, the treatment procedures were the same as the MTA group, and before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area after bleeding control to provide biostimulation. Patients were called for followup appointments at 1, 3, 6 and 12 months after treatment and control radiographs were taken.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

April 19, 2019

Last Update Submit

July 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • presence of spontaneous pain, percussion, palpation, mobility, presence of fistula, swelling of the mucosa, loss of lamina dura, internal or external root resorption and periapical radiolucency

    Presence of pathological findings were scored as 1, absence was scored as 0

    First, third, sixth and twelfth month

Study Arms (2)

Laser+MTA group

EXPERIMENTAL

before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area

Procedure: Partial pulpotomy with laser+MTA

MTA group

ACTIVE COMPARATOR

MTA was applied to the exposed area

Procedure: Partial pulpotomy with MTA

Interventions

After removing caries, laser+MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.

Laser+MTA group

After removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.

MTA group

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of immature molar tooth with deep dentin caries.

You may not qualify if:

  • History of any systematic disease Uncompliance with dental treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, 71200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2019

First Posted

July 8, 2019

Study Start

January 8, 2018

Primary Completion

January 14, 2019

Study Completion

January 14, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations