Skip to main content
OpenTrials
Completed

NCT Number: NCT07263763

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Odonto-Stomatology

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

About this study

Gingival enlargement is a frequent periodontal manifestation in patients undergoing fixed orthodontic treatment, primarily resulting from increased plaque retention and subsequent chronic inflammation. This condition can compromise esthetics, interfere with effective oral hygiene, and lead to periodontal complications if left untreated. Gingivectomy is the treatment of choice for removing excess gingival tissue and reestablishing physiological gingival contours. Conventional scalpel gingivectomy has been widely used; however, the advent of laser technology, particularly diode lasers, has provided an alternative surgical approach with potential clinical advantages, including better hemostasis, reduced intraoperative discomfort, faster wound healing, and less postoperative pain.

This study is designed as a randomized split-mouth clinical trial to compare the clinical and microbiological outcomes of gingivectomy performed using a scalpel versus a diode laser in orthodontic patients with gingival enlargement. Eligible participants will be recruited from the Orthodontics Department of the Ho Chi Minh City National Hospital of Odonto-Stomatology. Each patient will undergo gingivectomy on two contralateral quadrants: one quadrant treated with conventional scalpel surgery (control side) and the other with diode laser surgery (test side). The allocation of quadrants will be randomized.

Clinical parameters including Plaque Index (PlI), Gingival Index (GI), Probing Pocket Depth (PPD), Gingival Margin Position (GMP), and Bleeding on Probing (BoP) will be recorded at baseline and at multiple postoperative intervals. Subgingival plaque samples will be collected for microbiological analysis using real-time polymerase chain reaction (qPCR) to evaluate the presence and levels of periodontopathogenic bacteria. Patient-reported outcomes such as postoperative pain will also be assessed using a visual analog scale (VAS).

All surgical procedures will be performed by the same calibrated operator to minimize variability. Standardized oral hygiene instructions will be provided to all participants throughout the study period. The collected data will be analyzed to determine differences in clinical healing, microbial changes, and patient comfort between the two treatment modalities. The findings are expected to provide evidence-based insights into the advantages and limitations of diode laser gingivectomy compared with the traditional scalpel technique in orthodontic patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scalpel Gingivectomy

Procedure

Conventional gingivectomy performed using a surgical scalpel. Gingival overgrowth was excised using standard surgical technique under local anesthesia.

Diode laser Gingivectomy

Procedure

Gingivectomy performed using a diode laser. Laser parameters were set according to manufacturer's recommendations. No sutures required.

Primary outcomes

  1. Gingival margin position

    Time frame: 1 month and 3 months after gingivectomy

    Reduction in Gingival Overgrowth Index

Secondary outcomes

  1. Probing Pocket Depth (PPD) Reduction

    Time frame: 1 month and 3 months after gingivectomy

    Changes in probing pocket depth at baseline and follow-up to assess periodontal healing response.

  2. Reduction in Gingival Index (GI)

    Time frame: 1 month and 3 months after gingivectomy

    Changes in gingival inflammation as assessed by the Löe and Silness Gingival Index at baseline, 1 month and 3 months after treatment.

  3. Reduction in Plaque Index (PlI)

    Time frame: 1 month and 3 months after gingivectomy

    Changes in plaque accumulation as measured by the Silness and Löe Plaque Index at baseline, 1 month and 3 months post-treatment.

  4. Reduction in Bleeding on Probing (BoP)

    Time frame: 1 month and 3 months after gingivectomy

    Changes in bleeding on probing percentage recorded at baseline, 1 month and 3 months after treatment to evaluate periodontal health response.

  5. Microbiological changes in subgingival plaque

    Time frame: 1 month and 3 months after gingivectomy

    hanges in subgingival bacterial composition (e.g., total bacterial load, presence of periodontal pathogens) between baseline, 1 month and 3 months after treatment.

  6. Postoperative pain score

    Time frame: 1 day, 3 days and 7 days after gingivectomy

    Patient-reported pain intensity measured using the Visual Analog Scale (VAS) to compare postoperative discomfort between treatment groups.

  7. Post-surgical bleeding

    Time frame: 1 day, 3 days and 7 days post-surgery

    Assessment of postoperative bleeding severity and duration based on clinical observation and patient reports, to compare healing response between scalpel and diode laser techniques.

Sponsors and collaborators

Lead sponsor

Nguyen Thu Thuy

Other

Registry information

Official study title

Clinical and Microbiological Characteristics of Orthodontic Patients With Fixed Appliances Treated for Gingival Hyperplasia Using Surgical Scalpel and Diode Laser: A Randomized Clinical Trial.

Acronym: GINGILASCA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.