NCT03748498

Brief Summary

This study was designed as a randomized, placebo-controlled trial of 2 groups. The treatment procedures were performed by one operator. After local anesthesia and rubber dam isolation, access cavity preparation was performed by diamond burs with high-speed hand pieces under the water cooling. . Instrumentation of procedures was performed by Reciproc R50 files. Irrigation protocol was completed, canal were dried, filled with gutta-percha cones and AH Plus sealer. After chemo- mechanical instrumentation and root canal filling procedures, LLLT was applied for 60 second per tooth using Nd-YAG laser ( λ=1064 nm,100 mJ, 10 Hz, 1-W) The same procedures as in the laser group were performed, been completed but the laser was not activated in this group. These patients were assigned as placebo group. Postoperative pain was measured and documented via the Visual Analogue Scale. Chi-square test was performed in analysis of the nominal data.There was statistically significant difference between groups at the 12th and 24th hours (p\<.05). ). However, no statistically significant difference was found between the groups at the 4th, 8th, 48th, and 72th hours (p\>.05). No statistically significant differences were detected between the groups in terms of demographic data (age and tooth number) except for gender (P \> .05).LLLT can decrease postoperative pain after root canal treatment of single rooted teeth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

November 19, 2018

Last Update Submit

November 19, 2018

Conditions

Keywords

laserpulpitispain

Outcome Measures

Primary Outcomes (1)

  • Pain Evaluation

    Postoperative pain was measured and documented via the Visual Analogue Scale (VAS). VAS consists of a 100 mm line which is represented at one end by a sign 'No pain' and at the other end 'unbearable pain'.

    3 day

Study Arms (2)

laser group

EXPERIMENTAL

Low level laser was applied for 60 second per tooth using Nd-YAG laser.

Device: laser

placebo group

PLACEBO COMPARATOR

The same procedures as in the laser group were performed, been completed but the laser was not activated in this group.

Device: laser

Interventions

laserDEVICE

Application of the laser was performed through root canal and to the buccal mucosa over the apices of the target tooth

laser groupplacebo group

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Root canal treatment was planned for patients who participated in this study and have single root and single canal. Patients aged between 15 to 45 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePulpitisPain

Interventions

Lasers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • ELİF BAHAR ÇAKICI, ASST. PROF.

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
All procedures were conducted by one clinician , and assignment was concealed from the clinician who performed the laser applications.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was designed as a randomized, placebo-controlled trial of 2 groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 21, 2018

Study Start

September 1, 2017

Primary Completion

March 12, 2018

Study Completion

March 15, 2018

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations