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Biostimulation After Tooth Extraction

Primary Purpose

Dental Caries in Children, Wound Heal

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tooth extraction
Sponsored by
Hazal Özer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Caries in Children

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Control Group

    Low- Level Laser Group (Doctor Smile Wiser)

    Arm Description

    No application was made after the tooth extraction procedure in the control group.

    In the Laser group, the diode laser device Doctor Smile Wiser (Wiser, Doctor Smile, Milan, Italy) (Figue 1) with a wavelength of 980 nm and a power of 0.5 W was used for LLLT. During the procedure, the patient, physician, and assistant staff wore protective glasses (Wiser, Doctor Smile, Milan, Italy). With 300 mW of energy, a 400 m tip held 1 cm away from the extraction socket was applied to the extraction socket for 60 seconds from three points determined from the vestibule, lingual/palatal, and occlusal surfaces.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 21, 2023
    Last Updated
    August 25, 2023
    Sponsor
    Hazal Özer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06018584
    Brief Title
    Biostimulation After Tooth Extraction
    Official Title
    Effect of Low-Level Laser Therapy in Wound Healing and Post-Operative Pain Management of Primary Molar Teeth Ex-traction: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    April 1, 2018 (Actual)
    Study Completion Date
    May 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hazal Özer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries in Children, Wound Heal

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Sham Comparator
    Arm Description
    No application was made after the tooth extraction procedure in the control group.
    Arm Title
    Low- Level Laser Group (Doctor Smile Wiser)
    Arm Type
    Experimental
    Arm Description
    In the Laser group, the diode laser device Doctor Smile Wiser (Wiser, Doctor Smile, Milan, Italy) (Figue 1) with a wavelength of 980 nm and a power of 0.5 W was used for LLLT. During the procedure, the patient, physician, and assistant staff wore protective glasses (Wiser, Doctor Smile, Milan, Italy). With 300 mW of energy, a 400 m tip held 1 cm away from the extraction socket was applied to the extraction socket for 60 seconds from three points determined from the vestibule, lingual/palatal, and occlusal surfaces.
    Intervention Type
    Other
    Intervention Name(s)
    Tooth extraction
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Wound healing
    Description
    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.
    Time Frame
    intervention (tooth extraction) day, 3rd day and 7th day
    Title
    Pain score
    Description
    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.
    Time Frame
    intervention day (tooth extraction), 3rd day and 7th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The IPD can be shared when the paper is published.
    IPD Sharing Time Frame
    From 2024 January for five years
    IPD Sharing Access Criteria
    The e-mail requests will be considered.

    Learn more about this trial

    Biostimulation After Tooth Extraction

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