- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04367324
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
Conditions
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
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Ordu, Turkey, 52200
- Ordu University
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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:
- 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
Exclusion Criteria:
- 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
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
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The low-level laser was applied to each patient in low-level laser therapy group.
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Control
No low-level laser application
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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.
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7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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