Frenulum; HypertrophyNCT04368715
Pain Perception and Wound Healing After Laser-assisted Frenectomy in Children
A study testing Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser in people with Frenulum; Hypertrophy, run by Trakya University.
Trial summary
This study is based on the records of the patients treated for labial frenectomy with a dental laser at the Department of Padiatric Dentistry from January 2017 to December 2017. Patients younger than 15 years were included and in total 22 patients who matched the inclusion criteria were investigated in the study. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Frenulum; Hypertrophy
- What is being tested?
- Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2019
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 8-13
- Patients with high frenulum insertion
- Patients without any systemic condition
- Patients treated with either treated Er:Cr;YSGG or 940 nm diode laser for labial frenectomy
- Patients who were followed up after day 1,7 and 14 for wound healing.
- Patients who were followed up after 3 hours, 1,7,14 days for pain perception
Who cannot join
- Patients with systemic condition
- Patients who were not treated with Er:Cr;YSGG or 940 nm diode laser for labial frenectomy
- Patients whose follow up was not properly completed
About this study
Official title: Evaluation of Pain Perception and Wound Healing After Laser-assisted Frenectomy in Pediatric Patients: a Retrospective Comparative Study
This study is based on the records of the patients treated for labial frenectomy with a dental laser at the Department of Padiatric Dentistry from January 2017 to December 2017. Patients younger than 15 years were included and in total 22 patients who matched the inclusion criteria were investigated in the study. The analyzed data included age, gender, frenelum insertion type, type of dental laser, and postoperative pain perception.
Read the detailed description
This study is based on the records of the patients who received laser-assisted frenectomy treatment due to mucogingival problems at pediatric dentistry department during two year period. Twenty-two patients treated with either Er,Cr:YSGG laser 2780 nm or 940 nm diode laser were selected who fulfilled the study's inclusion criteria. The analyzed data included age, gender, frenelum insertion type, type of dental laser, postoperative pain perception and wound healing. Post-operative pain was reported with Wong-Baker Faces Pain Rating Scale after 3 hours 1, 7 and 14 days. Wound surface healing was evaluated through photography. Images were uploaded to the software and the changes in the wound area were measured in square millimeters at the day of frenectomy and on days 1, 7, and 14 postoperatively.
- Conditions
- Frenulum; Hypertrophy
- Being tested
- Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laserDevice
| Study group | Role | What they receive |
|---|---|---|
| 2780 nm Er:Cr;YSGG laser treated group | Experimental | Patients treated with Er:Cr;YSGG laser for labial frenectomy Receives: Device: Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser |
| 940 nm Diode laser treated group | Experimental | Patients treated with 940 nm Diode laser for labial frenectomy Receives: Device: Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of pain perception changes after laser assisted frenectomy procedure
Evaluation of changes in pain scores were evaluated with Wong-Baker Faces Pain Rating Scale which consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Children were asked to select the facial expression that best represented their pain. Score 1 represents there is no pain, score 5 presents moderate pain and score 10 is the higher score which represents the worst pain.
Measured: After 3 hours, 1, 3, 7 and 14 postoperative days.
Assessment of wound surface area measurement changes after laser assisted frenectomy procedure
Evalution of wound healing. Remaining wound area (RWA): The defect area was measured after 1, 3, 7 and 14 postoperative days.
Measured: 1, 3, 7 and 14 postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frenulum; HypertrophyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞİRİN GÜNER ONUR, Trakya University
- Investigators
- SIRIN GUNER ONUR, PhD, Study chair, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368715
- Sponsor's protocol ID
- TUTF-BAEK 2019/481
- Status last verified
- May 2020
- First submitted
- 23 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Onur SG. Evaluation of Pain Perception and Wound Healing After Laser-Assisted Frenectomy in Pediatric Patients: A Retrospective Comparative Study. Photobiomodul Photomed Laser Surg. 2021 Mar;39(3):204-210. doi: 10.1089/photob.2020.4886. Epub 2020 Dec 18.
PubMed 33337937
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Perception and Wound Healing After Laser-assisted Frenectomy in Pediatric Patients: a Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT04368715
- Acronym / sponsor ID
- TUTF-BAEK 2019/481
- Conditions
- Frenulum; Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 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.
This study is based on the records of the patients treated for labial frenectomy with a dental laser at the Department of Padiatric Dentistry from January 2017 to December 2017. Patients younger than 15 years were included and in total 22 patients who matched the inclusion criteria were investigated in the study. The analyzed data included age, gender, frenelum insertion type, type of dental laser, and postoperative pain perception.
Detailed description
This study is based on the records of the patients who received laser-assisted frenectomy treatment due to mucogingival problems at pediatric dentistry department during two year period. Twenty-two patients treated with either Er,Cr:YSGG laser 2780 nm or 940 nm diode laser were selected who fulfilled the study's inclusion criteria. The analyzed data included age, gender, frenelum insertion type, type of dental laser, postoperative pain perception and wound healing. Post-operative pain was reported with Wong-Baker Faces Pain Rating Scale after 3 hours 1, 7 and 14 days. Wound surface healing was evaluated through photography. Images were uploaded to the software and the changes in the wound area were measured in square millimeters at the day of frenectomy and on days 1, 7, and 14 postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2780 nm Er:Cr;YSGG laser treated group | Experimental | Device: Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laserPatients treated with Er:Cr;YSGG laser for labial frenectomy |
| 940 nm Diode laser treated group | Experimental | Device: Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laserPatients treated with 940 nm Diode laser for labial frenectomy |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 8-13
- Patients with high frenulum insertion
- Patients without any systemic condition
- Patients treated with either treated Er:Cr;YSGG or 940 nm diode laser for labial frenectomy
- Patients who were followed up after day 1,7 and 14 for wound healing.
Key exclusion criteria (3 listed)
- Patients with systemic condition
- Patients who were not treated with Er:Cr;YSGG or 940 nm diode laser for labial frenectomy
- Patients whose follow up was not properly completed
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 |
|---|---|---|
| Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser | Device | 2780 nm Er:Cr;YSGG laser treated group, 940 nm Diode laser treated group |
Primary outcome
Assesment of pain perception changes after laser assisted frenectomy procedure
Time frame: After 3 hours, 1, 3, 7 and 14 postoperative days.
Evaluation of changes in pain scores were evaluated with Wong-Baker Faces Pain Rating Scale which consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Children were asked to select the facial expression that best represented their pain. Score 1 represents there is no pain, score 5 presents moderate pain and score 10 is the higher score which represents the worst pain.
Assessment of wound surface area measurement changes after laser assisted frenectomy procedure
Time frame: 1, 3, 7 and 14 postoperative days.
Evalution of wound healing. Remaining wound area (RWA): The defect area was measured after 1, 3, 7 and 14 postoperative days.
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 5 May 2020.
- Derived from this study: PubMed 33337937Onur SG. Evaluation of Pain Perception and Wound Healing After Laser-Assisted Frenectomy in Pediatric Patients: A Retrospective Comparative Study. Photobiomodul Photomed Laser Surg. 2021 Mar;39(3):204-210. doi: 10.1089/photob.2020.4886. Epub 2020 Dec 18.
- Individual participant dataSharing planned: No
Related trials for Frenulum; Hypertrophy
Not yet recruiting
970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy
Maxillary Labial Frenulum Abnormality, Hypertrophic Maxillary Labial Frenulum
Not yet recruiting
Diode Laser Versus Conventional Frenectomy in Children
Frenulum; Hypertrophy, Diode Laser
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.
SIRIN GUNER ONUR, PhD study chair
Trakya University
Questions about this trial
What is this clinical trial studying?
A study testing Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser in people with Frenulum; Hypertrophy, run by Trakya University.
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 6 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 5 May 2020. 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. 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?
Assesment of pain perception changes after laser assisted frenectomy procedure (time frame: After 3 hours, 1, 3, 7 and 14 postoperative days.). 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?
On the ClinicalTrials.gov record for NCT04368715, which also lists 1 linked publication.
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 5 May 2020.