Low-level Laser TherapyNCT04367324
Effect of Low-Level Laser Therapy Following Direct Pulp Capping on Postoperative Sensitivity by Thermal Stimulus
An observational study of Low-level Laser Therapy, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-level Laser Therapy
- What is being tested?
- Low-level laser therapy
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2017to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Low-level Laser Therapy
- Being tested
- Low-level laser therapy
- Keywords
- direct pulp capping, low level laser therapy, thermal stimulus, biostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyDevice
The low-level laser was applied to each patient in low-level laser therapy group.
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Applied the low-level laser irradiation Receives: Device: Low-level laser therapy | |
| Control | No low-level laser application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Oct 2017
- Primary completion1 Oct 2018
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-level Laser TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adem Günaydin, Ordu University
- Investigators
- Adem Günaydın, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367324
- Sponsor's protocol ID
- Ordu
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Level Laser Therapy Following Direct Pulp Capping on Postoperative Sensitivity by Thermal Stimulus: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04367324
- Acronym / sponsor ID
- Ordu
- Conditions
- Low-level Laser Therapy
- Keywords
- direct pulp capping, low level laser therapy, thermal stimulus, biostimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | – | Device: Low-level laser therapyApplied the low-level laser irradiation |
| Control | – | –No low-level laser application |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-level laser therapyThe low-level laser was applied to each patient in low-level laser therapy group. | Device | Low level laser therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adem Günaydın principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low-level Laser Therapy, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of low-level laser therapy following direct pulp capping on postoperative sensitivity as assessed by visual analog scale. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.