Effect of Low-Level Laser Therapy Following Direct Pulp Capping on Postoperative Sensitivity by Thermal Stimulus

April 29, 2020 updated by: Adem Günaydin, T.C. ORDU ÜNİVERSİTESİ

Effect of Low-Level Laser Therapy Following Direct Pulp Capping on Postoperative Sensitivity by Thermal Stimulus: A Retrospective Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ordu, Turkey, 52200
        • Ordu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low level laser therapy
Applied the low-level laser irradiation
The low-level laser was applied to each patient in low-level laser therapy group.
Control
No low-level laser application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of low-level laser therapy following direct pulp capping on postoperative sensitivity as assessed by visual analog scale.
Time Frame: 7 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Adem Günaydın, T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

October 1, 2019

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 25, 2020

First Posted (ACTUAL)

April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ordu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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