Gingival Hyperplasia Treatment With Surgical Scalpel vs Diode Laser in Orthodontic Patients.
NCT ID: NCT07263763
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2024-08-01
2025-02-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Scalpel Gingivectomy
Conventional gingivectomy performed using a surgical scalpel. Gingival overgrowth was excised using standard surgical technique under local anesthesia.
Scalpel Gingivectomy
Conventional gingivectomy performed using a surgical scalpel. Gingival overgrowth was excised using standard surgical technique under local anesthesia.
Diode Laser Gingivectomy
Gingivectomy performed using a diode laser. Laser parameters were set according to manufacturer's recommendations. No sutures required.
Diode laser Gingivectomy
Gingivectomy performed using a diode laser. Laser parameters were set according to manufacturer's recommendations. No sutures required.
Interventions
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Scalpel Gingivectomy
Conventional gingivectomy performed using a surgical scalpel. Gingival overgrowth was excised using standard surgical technique under local anesthesia.
Diode laser Gingivectomy
Gingivectomy performed using a diode laser. Laser parameters were set according to manufacturer's recommendations. No sutures required.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Nguyen Thu Thuy
OTHER
Responsible Party
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Nguyen Thu Thuy
Associate Professor - PhD
Principal Investigators
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Thi Hong Nhung Nguyen
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy at Ho Chi Minh City
Locations
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University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Odonto-Stomatology
Ho Chi Minh City, Ho Chi Minh, Vietnam
Countries
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References
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Newman MG, Takei H, Klokkevold PR, Carranza FA. Newman and Carranza's Clinical Periodontology and Implantology. 14th ed. St. Louis: Elsevier / Saunders; 2023.
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.
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.
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.
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.
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.
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.
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.
Related Links
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University of Medicine and Pharmacy at Ho Chi Minh City
Other Identifiers
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1427/ĐHYD-HĐĐĐ
Identifier Type: OTHER
Identifier Source: secondary_id
1427/ĐHYD-HDDD
Identifier Type: -
Identifier Source: org_study_id
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