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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06018584
Other study ID # 2017-07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2016
Est. completion date May 1, 2018

Study information

Verified date August 2023
Source Necmettin Erbakan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluated the effect of low-level laser therapy on postoperative pain and wound healing in children undergoing primary molar extractions 40children, 6-10 years of age, systemically healthy, and had atraumatic extraction indications of bilateral primary molar teeth were included in the study. A randomly selected tooth was extracted under local anesthesia in the first session. Only the clot formation on the socket was observed and photographed in the control group. Other group extractions were performed 2weeks later. The LLLT group was treated with a 980 nm wavelength Doctor Smile Wiser diode laser and photographed. Non-epithelialized surface measurements were performed with the ImageJ program. Pain assessment was performed with the Wong-Baker Pain Scale. Statistical analyses were performed with SPSS software.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 1, 2018
Est. primary completion date April 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - indication for tooth extraction in bilateral primary molars - did not have any systemic disease - the use of antibiotics and painkillers was stopped at least 12 hours ago Exclusion Criteria: - require complicated tooth extractions - systemic disease - the use of antibiotics and painkillers in 12 hours

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tooth extraction
Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hazal Özer

Outcome

Type Measure Description Time frame Safety issue
Primary Wound healing For the evaluation of soft tissue healing in extraction sockets, intraoral photographs were taken at an angle of 60° to the occlusal surface on the 3rd and 7th days following the extraction session. Non-epithelialized surface measurements were made by two observing physicians using the ImageJ (NIH, Rockville, USA) program. intervention (tooth extraction) day, 3rd day and 7th day
Primary Pain score Pain assessment in both groups was performed with the Wong-Baker Pain Rating Scale (Wong-Baker FACES Pain Rating Scale PRS). Patients were asked to choose a face or number from the scale, and the selected value was the practitioner dentist on the day of the procedure; other days were recorded by the parent. This scale is graded from 0 to 10. 0 indicates no pain, and 10 marks the most severe pain. It is asked to evaluate the pain according to the facial expression. intervention day (tooth extraction), 3rd day and 7th day
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