Gingival EnlargementGINGILASCANCT07263763
Gingival Hyperplasia Treatment With Surgical Scalpel vs Diode Laser in Orthodontic Patients.
A study testing Scalpel Gingivectomy and Diode laser Gingivectomy in people with Gingival Enlargement, run by Nguyen Thu Thuy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Enlargement
- What is being tested?
- Scalpel Gingivectomy and Diode laser Gingivectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of Odonto-Stomatology
Ho Chi Minh City, Ho Chi Minh, 700000
About this study
Official 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.
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.
Read the detailed description
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.
- Conditions
- Gingival Enlargement
- Being tested
- Scalpel Gingivectomy, Diode laser Gingivectomy
- Keywords
- Gingival overgrowth, Gingival enlargement, Orthodontic treatment, Laser gingivectomy, Surgical gingivectomy, Diode laser, Fixed orthodontic appliances, Randomized clinical trial
- Medical subject headings
- Gingival Hyperplasia, Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalpel GingivectomyProcedure or surgery
Conventional gingivectomy performed using a surgical scalpel. Gingival overgrowth was excised using standard surgical technique under local anesthesia.
Diode laser GingivectomyProcedure or surgery
Gingivectomy performed using a diode laser. Laser parameters were set according to manufacturer's recommendations. No sutures required.
| Study group | Role | What they receive |
|---|---|---|
| Scalpel Gingivectomy | Experimental | Conventional gingivectomy performed using a surgical scalpel. Gingival overgrowth was excised using standard surgical technique under local anesthesia. Receives: 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. Receives: Procedure: Diode laser Gingivectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival margin position
Reduction in Gingival Overgrowth Index
Measured: 1 month and 3 months after gingivectomy
Secondary outcomes (7)
Probing Pocket Depth (PPD) Reduction
Changes in probing pocket depth at baseline and follow-up to assess periodontal healing response.
Measured: 1 month and 3 months after gingivectomy
Reduction in Gingival Index (GI)
Changes in gingival inflammation as assessed by the Löe and Silness Gingival Index at baseline, 1 month and 3 months after treatment.
Measured: 1 month and 3 months after gingivectomy
Reduction in Plaque Index (PlI)
Changes in plaque accumulation as measured by the Silness and Löe Plaque Index at baseline, 1 month and 3 months post-treatment.
Measured: 1 month and 3 months after gingivectomy
Reduction in Bleeding on Probing (BoP)
Changes in bleeding on probing percentage recorded at baseline, 1 month and 3 months after treatment to evaluate periodontal health response.
Measured: 1 month and 3 months after gingivectomy
Microbiological changes in subgingival plaque
hanges in subgingival bacterial composition (e.g., total bacterial load, presence of periodontal pathogens) between baseline, 1 month and 3 months after treatment.
Measured: 1 month and 3 months after gingivectomy
Postoperative pain score
Patient-reported pain intensity measured using the Visual Analog Scale (VAS) to compare postoperative discomfort between treatment groups.
Measured: 1 day, 3 days and 7 days after gingivectomy
Post-surgical bleeding
Assessment of postoperative bleeding severity and duration based on clinical observation and patient reports, to compare healing response between scalpel and diode laser techniques.
Measured: 1 day, 3 days and 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Aug 2024
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gingival EnlargementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nguyen Thu Thuy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nguyen Thu Thuy, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Thi Hong Nhung Nguyen, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263763
- Sponsor's protocol ID
- 1427/ĐHYD-HDDD
- Other IDs
- 1427/ĐHYD-HĐĐĐ
- Acronym
- GINGILASCA
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared because the study is conducted as part of a postgraduate thesis with a limited scope and without a formal data sharing agreement.
Publications
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.
PubMed 14158464Krishnan 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.
PubMed 17975951Maboudi 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.
PubMed 37738371Lione 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.
PubMed 31111882Zanatta 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.
PubMed 23186371Gong 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.
PubMed 21724088
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07263763
- Acronym / sponsor ID
- GINGILASCA / 1427/ĐHYD-HDDD
- Conditions
- Gingival Enlargement
- Keywords
- Gingival overgrowth, Gingival enlargement, Orthodontic treatment, Laser gingivectomy, Surgical gingivectomy, Diode laser, Fixed orthodontic appliances, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nguyen Thu ThuyUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Scalpel Gingivectomy | Experimental | Procedure: Scalpel GingivectomyConventional gingivectomy performed using a surgical scalpel. Gingival overgrowth was excised using standard surgical technique under local anesthesia. |
| Diode Laser Gingivectomy | Experimental | Procedure: Diode laser GingivectomyGingivectomy performed using a diode laser. Laser parameters were set according to manufacturer's recommendations. No sutures required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalpel GingivectomyConventional gingivectomy performed using a surgical scalpel. Gingival overgrowth was excised using standard surgical technique under local anesthesia. | Procedure or surgery | Scalpel Gingivectomy |
| Diode laser GingivectomyGingivectomy performed using a diode laser. Laser parameters were set according to manufacturer's recommendations. No sutures required. | Procedure or surgery | Diode Laser Gingivectomy |
Primary outcome
Gingival margin position
Time frame: 1 month and 3 months after gingivectomy
Reduction in Gingival Overgrowth Index
7 secondary outcomes
Probing Pocket Depth (PPD) Reduction
Time frame: 1 month and 3 months after gingivectomy
Reduction in Gingival Index (GI)
Time frame: 1 month and 3 months after gingivectomy
Reduction in Plaque Index (PlI)
Time frame: 1 month and 3 months after gingivectomy
Reduction in Bleeding on Probing (BoP)
Time frame: 1 month and 3 months after gingivectomy
Microbiological changes in subgingival plaque
Time frame: 1 month and 3 months after gingivectomy
Postoperative pain score
Time frame: 1 day, 3 days and 7 days after gingivectomy
Post-surgical bleeding
Time frame: 1 day, 3 days and 7 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publicationNewman MG, Takei H, Klokkevold PR, Carranza FA. Newman and Carranza's Clinical Periodontology and Implantology. 14th ed. St. Louis: Elsevier / Saunders; 2023.
- Results publication: PubMed 14158464SILNESS 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.
- Results publicationKrishnan 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.
- Results publication: PubMed 17975951Fornaini 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.
- Results publication: PubMed 37738371Maboudi 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.
- Results publication: PubMed 31111882Lione 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.
- Results publication: PubMed 23186371Zanatta 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.
- Results publication: PubMed 21724088Gong 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.
- University of Medicine and Pharmacy at Ho Chi Minh CityLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared because the study is conducted as part of a postgraduate thesis with a limited scope and without a formal data sharing agreement.
Related trials for Gingival Enlargement
Not yet recruiting
Diode Laser Versus Conventional Frenectomy in Children
Frenulum; Hypertrophy, Diode Laser
Enrolling by invitationEarly Phase 1
Testing the Efficacy of Photobiomodulation Therapy and Hyaluronic Acid Gel on Post-surgical Healing After Gingivectomy
Gingival Hyperplasia, Gingival Hypertrophy
Recruiting
The Effect of Ozone Therapy on Gingivoplasty
Gingival Enlargement
Recruiting
Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements
Localized Gingival Enlargement, Epulides
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thi Hong Nhung Nguyen principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalpel Gingivectomy and Diode laser Gingivectomy in people with Gingival Enlargement, run by Nguyen Thu Thuy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival margin position (time frame: 1 month and 3 months after gingivectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07263763, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.