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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04367324
Other study ID # Ordu
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date October 1, 2019

Study information

Verified date April 2020
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date October 1, 2019
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Ordu University Ordu

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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