Maxillary Labial Frenectomy: Diode Lasers Versus Surgical Scalpel
Turkey (Türkiye)43 participantsStarted 2024-04-01
Plain-language summary
The goal of this clinical trial is to determine if diode laser treatment can improve post-operative outcomes compared to conventional scalpel technique in systemically healthy, non-smoking adults aged 18-45 years with aberrant papillary frenum attachment. The main questions it aims to answer are:
Does diode laser treatment result in lower post-operative pain compared to the conventional scalpel technique? Does diode laser treatment result in better periodontal healing outcomes compared to the conventional scalpel technique? Researchers will compare the diode laser surgery group to the conventional scalpel surgery group to see if there are differences in pain and healing.
Participants will:
Undergo a frenectomy procedure using either a diode laser or a conventional scalpel.
Receive oral hygiene instructions and post-operative care recommendations. Have their periodontal parameters measured at baseline, 6 weeks, and 6 months post-operation.
Record their pain levels using a visual analogue scale on specified post-operative days.
Who can participate
Age range
18 Years – 45 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:
* Systemically healthy
* Nonsmoker
* No periodontal treatment received in the last 3 months
* Having at least 20 teeth
* Presence of at least central incisors, lateral incisors, and canines in the maxilla
* Not pregnant or breastfeeding
* No psychiatric, mental, or physical impairments
* Diagnosed with gingival health based on the "World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
* Consent to participate in the study.
Exclusion Criteria:
* Any systemic disease that could interfere with the wound healing process (e.g., diabetes mellitus and HIV infection)
* Smoking
* Use of antibiotics, anti-inflammatory drugs, or any other medication in the last 6 months that could affect the study's outcome
* Any hypersensitivity reactions to paracetamol
* Any physical limitations or restrictions that could impede normal oral hygiene procedures.
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
Timeframe: postoperative days 1, 3, 7, 14, 21, and 28.
2
Postoperative tissue healing
Timeframe: postoperative days 7 and 30 after surgery,