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

NCT07263763 | Completed

• 2 other identifiers: 1427/ĐHYD-HDDD1427/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Enlargement

Keywords

Gingival overgrowth; Gingival enlargement; Orthodontic treatment; Laser gingivectomy; Surgical gingivectomy; Diode laser; Fixed orthodontic appliances; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Gingival margin position

  Reduction in Gingival Overgrowth Index

  1 month and 3 months after gingivectomy

Secondary Outcomes (7)

• Probing Pocket Depth (PPD) Reduction

  1 month and 3 months after gingivectomy

• Reduction in Gingival Index (GI)

  1 month and 3 months after gingivectomy

• Reduction in Plaque Index (PlI)

  1 month and 3 months after gingivectomy

• Reduction in Bleeding on Probing (BoP)

  1 month and 3 months after gingivectomy

• Microbiological changes in subgingival plaque

  1 month and 3 months after gingivectomy

Study Arms (2)

Scalpel Gingivectomy

EXPERIMENTAL

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

Procedure: Scalpel Gingivectomy

Diode Laser Gingivectomy

EXPERIMENTAL

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

Procedure: Diode laser Gingivectomy

Interventions

Scalpel Gingivectomy PROCEDURE

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

Scalpel Gingivectomy

Diode laser Gingivectomy PROCEDURE

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

Diode Laser Gingivectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nguyen Thu Thuy: lead

Study Sites (1)

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

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

Location

Related Publications (8)

• Newman MG, Takei H, Klokkevold PR, Carranza FA. Newman and Carranza's Clinical Periodontology and Implantology. 14th ed. St. Louis: Elsevier / Saunders; 2023.

  RESULT

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 RESULT

• Krishnan V, Ambili R, Davidovitch Z, Murphy NC. Gingiva and Orthodontic Treatment. Semin Orthod. 2007;13(4):257-271. doi:10.1053/j.sodo.2007.08.007.

  RESULT

• Fornaini C, Rocca JP, Bertrand MF, Merigo E, Nammour S, Vescovi P. Nd:YAG and diode laser in the surgical management of soft tissues related to orthodontic treatment. Photomed Laser Surg. 2007 Oct;25(5):381-92. doi: 10.1089/pho.2006.2068.

  PMID: 17975951 RESULT

• Maboudi A, Fekrazad R, Shiva A, Salehabadi N, Moosazadeh M, Ehsani H, Yazdani O. Gingivectomy with Diode Laser Versus the Conventional Scalpel Surgery and Nonsurgical Periodontal Therapy in Treatment of Orthodontic Treatment-Induced Gingival Enlargement: A Systematic Review. Photobiomodul Photomed Laser Surg. 2023 Sep;41(9):449-459. doi: 10.1089/photob.2023.0060.

  PMID: 37738371 RESULT

• Lione R, Pavoni C, Noviello A, Clementini M, Danesi C, Cozza P. Conventional versus laser gingivectomy in the management of gingival enlargement during orthodontic treatment: a randomized controlled trial. Eur J Orthod. 2020 Jan 27;42(1):78-85. doi: 10.1093/ejo/cjz032.

  PMID: 31111882 RESULT

• Zanatta FB, Ardenghi TM, Antoniazzi RP, Pinto TM, Rosing CK. Association between gingival bleeding and gingival enlargement and oral health-related quality of life (OHRQoL) of subjects under fixed orthodontic treatment: a cross-sectional study. BMC Oral Health. 2012 Nov 27;12:53. doi: 10.1186/1472-6831-12-53.

  PMID: 23186371 RESULT

• Gong Y, Lu J, Ding X. Clinical, microbiologic, and immunologic factors of orthodontic treatment-induced gingival enlargement. Am J Orthod Dentofacial Orthop. 2011 Jul;140(1):58-64. doi: 10.1016/j.ajodo.2010.02.033.

  PMID: 21724088 RESULT

Related Links

• University of Medicine and Pharmacy at Ho Chi Minh City

MeSH Terms

Conditions

Gingival Hyperplasia; Gingival Overgrowth

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Thi Hong Nhung Nguyen

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, masking of participants and operators was not feasible. Outcome assessors were blinded to the type of intervention performed at each site.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor - PhD

Model Details: This is a randomized, split-mouth clinical trial using a crossover design. Each participant received both interventions (scalpel gingivectomy and diode laser gingivectomy) at different sites within the same arch.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: August 1, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)