CompletedNot Applicable

Gingival Hyperplasia Treatment With Surgical Scalpel vs Diode Laser in Orthodontic Patients.

Vietnam13 participantsStarted 2024-08-01

Plain-language summary

Gingival enlargement is a common complication in orthodontic patients, often resulting from plaque accumulation and chronic inflammatory response during fixed appliance therapy. Surgical gingivectomy is frequently required to restore gingival contour, improve esthetics, and facilitate oral hygiene. Traditionally, gingivectomy is performed using a scalpel, but laser-assisted techniques have recently gained popularity due to their potential benefits, including reduced bleeding, postoperative discomfort, and faster healing. This randomized split-mouth clinical trial aims to compare the clinical and microbiological outcomes of gingivectomy performed with a diode laser versus conventional scalpel surgery in orthodontic patients presenting with gingival enlargement. Clinical parameters, microbial profiles, and patient-reported outcomes will be evaluated at baseline and at multiple postoperative intervals to assess the effectiveness and advantages of each technique.

Who can participate

Age range

18 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: * Participants aged 18 years or older who agree to take part in the study. * Individuals in good general health with no history of systemic diseases. * Patients undergoing fixed orthodontic treatment with metallic brackets for at least 6 months and presenting with gingival enlargement. * Patients with good oral hygiene (Plaque Index \[PlI\] \< 1) and who comply with the instructions provided by the dentist during the treatment period. Exclusion Criteria: * History of using medications associated with gingival enlargement, such as anticonvulsants, immunosuppressants, or calcium channel blockers (e.g., phenytoin, cyclosporine, nifedipine, verapamil, diltiazem, felodipine, nitredipine, etc.). * Pregnant or breastfeeding women, or individuals using hormonal therapy. * Patients who have undergone periodontal treatment within the last 6 months. * Use of antibiotics within 3 months prior to study enrollment. * Presence or history of systemic diseases. * Patients who refuse the use of laser in treatment. * Patients who are uncooperative, have poor oral hygiene (PlI \> 1), discontinue participation during the study, or fail to follow instructions throughout the study period.

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

Gingival margin position

Timeframe: 1 month and 3 months after gingivectomy

Trial details

NCT IDNCT07263763

SponsorNguyen Thu Thuy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-15

View on ClinicalTrials.gov More Gingival Enlargement trials