NCT04367324

Brief Summary

The aim of this study was to investigate the effect of low-level laser therapy (LLLT) on postoperative pain provoked by thermal stimulation in direct pulp capping. All the patients who received consent form in this retrospective study were retrieved from the records of patients attended for routine dental treatment at the Ordu University, Faculty of Dentistry, Department of Endodontics between 01.10.2017-01.10.2018. Study subjects were recruited from the pool of patients who performed direct pulp capping by a single operator. A total of 123 pre-treated teeth of 123 patients who referred to Ordu University, Faculty of Dentistry were examined. Follow-up examinations were carried out at postoperative 6th hours, 1st and 7th days with visual analog scale (VAS), and treatment outcome were assessed. Participants were allocated to the laser and control group which consist of 42 patients in each group. 6 patients were excluded from the study due to missing data in both groups. Thus, data from 72 patients who had been carried out direct pulp capping were assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 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

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 24, 2020

Last Update Submit

April 29, 2020

Conditions

Keywords

direct pulp cappinglow level laser therapythermal stimulusbiostimulation

Outcome Measures

Primary Outcomes (1)

  • Effect of low-level laser therapy following direct pulp capping on postoperative sensitivity as assessed by visual analog scale.

    Postoperative sensitivity was assessed and documented via a visual analog scale. The visual analog scale consists of a 100 mm line which is represented at one end by a sign 'no pain' and at the other end 'unbearable pain'. This form was given to each patient and instructed to mark at home according to the pain intensity at 6th hours. Also, patients were seen 1 and 7 days postoperatively to mark the degree of pain on the visual analog scale. Patients were informed that the marking must be performed only when sensitivity induced by the cold stimulus. On a visual analog scale named postoperative sensitivity scale, '0' presents the minimum value and '10' presents the maximum value. High scores indicate a worse result, while low scores indicate a better result. Lower sensitivity was detected on the visual analog scale at 7th days in the low-level laser therapy group compared to the control group.

    7 days

Study Arms (2)

Low level laser therapy

Applied the low-level laser irradiation

Device: Low-level laser therapy

Control

No low-level laser application

Interventions

The low-level laser was applied to each patient in low-level laser therapy group.

Low level laser therapy

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All the participants in this study were retrieved from the pool of patients who attended for routine treatment at the Department of Endodontics at the University Hospital of Ordu between October 2017 and October 2018. Those patients who had received DPC treatment by a single operator were selected.

You may qualify if:

  • Mandibular and maxillary permanent molars with pulpal exposure between 0.5-1.0 mm
  • Periodontally healthy teeth (no more than 3mm probing depth)
  • Pulpal exposure occurring only on the occlusal side of the tooth
  • Systemically healthy participant
  • Participants who signed the written consent form
  • Patients aged 15-45
  • Patients who have not used analgesic or antibiotic in the past two weeks
  • Patients whose data are fully and accurately recorded
  • Patients who do not use immunosuppressive drugs and do not need antibiotic prophylaxis

You may not qualify if:

  • Patients who need a second anesthetic
  • Presence of a previous restoration of the tooth
  • Patients using psychiatric or sedative medication
  • Patients who had a direct pulp capping treatment on several teeth
  • Patients with tooth pain and unable to localize this pain
  • Patients taking pain medication within 1 week after the procedures
  • Patients with a lack of data during follow-up
  • Treated teeth without following clinical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Adem Günaydın

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 29, 2020

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2019

Last Updated

May 1, 2020

Record last verified: 2020-04

Locations