Dental Caries in ChildrenNCT06018584
Biostimulation After Tooth Extraction
A study testing Tooth extraction in people with Dental Caries in Children and Wound Heal, run by Hazal Özer.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Wound Heal
- What is being tested?
- Tooth extraction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 May 2018
- Phase
- Interventional
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- require complicated tooth extractions
- systemic disease
- the use of antibiotics and painkillers in 12 hours
About this study
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
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.
- Conditions
- Dental Caries in Children, Wound Heal
- Being tested
- Tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extractionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | No application was made after the tooth extraction procedure in the control group. Receives: Other: Tooth extraction |
| Low- Level Laser Group (Doctor Smile Wiser) | Experimental | 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. Receives: Other: Tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intervention (tooth extraction) day, 3rd day and 7th day
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.
Measured: intervention day (tooth extraction), 3rd day and 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Nov 2016
- Primary completion1 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hazal Özer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hazal Özer, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018584
- Sponsor's protocol ID
- 2017-07
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD can be shared when the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06018584
- Acronym / sponsor ID
- 2017-07
- Conditions
- Dental Caries in Children, Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hazal ÖzerUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 30 Aug 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Other: Tooth extractionNo application was made after the tooth extraction procedure in the control group. |
| Low- Level Laser Group (Doctor Smile Wiser) | Experimental | Other: Tooth extractionIn 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- require complicated tooth extractions
- systemic disease
- the use of antibiotics and painkillers in 12 hours
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 |
|---|---|---|
| Tooth extractionTooth 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. | Other | Control Group, Low- Level Laser Group (Doctor Smile Wiser) |
Primary outcome
Wound healing
Time frame: intervention (tooth extraction) day, 3rd day and 7th day
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
Time frame: intervention day (tooth extraction), 3rd day and 7th day
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.
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 30 Aug 2023.
- Individual participant dataSharing planned: Yes. The IPD can be shared when the paper is published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction in people with Dental Caries in Children and Wound Heal, run by Hazal Özer.
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 3 inclusion and 3 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Wound healing (time frame: intervention (tooth extraction) day, 3rd day and 7th day). The study lists 2 primary outcomes in all. 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 30 Aug 2023.