Pain After Diode Laser Frenectomy in Children (NCT07706023) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pain After Diode Laser Frenectomy in Children
Turkey (Türkiye)53 participantsStarted 2026-07-10
Plain-language summary
This prospective single-group clinical study aims to evaluate postoperative pain following diode laser-assisted frenectomy in pediatric patients and to assess the agreement between different pediatric pain assessment scales. Children aged 8 to 14 years who require diode laser-assisted frenectomy will be treated according to the standard clinical protocol at the Pediatric Dentistry Clinic of Afyonkarahisar Health Sciences University. Postoperative pain will be evaluated once daily for seven consecutive days using the Wong-Baker FACES Pain Rating Scale, the Modified Emoji Pain Scale (MEPS), and gender-specific pain assessment scales. The primary objective is to characterize the time course of postoperative pain during the first postoperative week. Secondary objectives include evaluating the agreement and correlation between the different pain assessment instruments used in pediatric patients. The findings are expected to contribute to the identification of reliable pain assessment methods and to improve postoperative pain evaluation following diode laser-assisted frenectomy in children.
Who can participate
Age range
8 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged 8 to 14 years.
* Patients requiring diode laser-assisted frenectomy based on clinical indication.
* American Society of Anesthesiologists (ASA) Physical Status I or II.
* Ability of the participant and parent/legal guardian to understand the study procedures.
* Written informed consent obtained from the parent or legal guardian, with assent obtained from the child when appropriate.
Exclusion Criteria:
* Presence of systemic diseases or medical conditions that could influence wound healing or pain perception.
* Current use of analgesic, anti-inflammatory, corticosteroid, or psychotropic medications.
* History of allergy or contraindication to local anesthetic agents.
* Acute oral infection at the surgical site.
* Previous oral soft tissue surgery in the same anatomical region.
* Inability or unwillingness to complete the postoperative pain assessment forms for seven consecutive days.
* Withdrawal of consent at any time during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Timeframe: Daily for 7 consecutive postoperative days
2
Postoperative Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Timeframe: Daily for 7 days after diode laser-assisted frenectomy