AnkyloglossiaNCT07557875
Healing Efficacy of Diode Laser in Lingual Frenectomy
A study testing Lingual Frenectomy using 940nm Diode Laser and Lingual Frenectomy using High-frequency Electrosurgery in people with Ankyloglossia and Tongue-tie, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
Trial summary
This study aims to compare the wound healing efficacy and postoperative experiences between the 940 nm diode laser technique and the traditional electrosurgery method for treating ankyloglossia (tongue-tie) in children aged 3 to 6 years. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Ankyloglossia, Tongue-tie
- What is being tested?
- Lingual Frenectomy using 940nm Diode Laser and Lingual Frenectomy using High-frequency Electrosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Oct 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged between 3 and 6 years.
- Diagnosed with grade 3 or grade 4 ankyloglossia according to Kotlow's classification (1999).
- Parents or legal guardians provide informed consent for the child to participate in the study.
- Patients and guardians agree to follow the follow-up schedule (24 hours, 3 days, 1 week, and 1 month post-surgery).
Who cannot join
- History of allergy to local anesthetics (e.g., Lidocaine, Adrenaline).
- Patients with systemic diseases or high-risk surgical factors (e.g., cardiovascular disease, bleeding disorders, hemophilia, epilepsy, or uncontrolled asthma).
- Uncooperative patients who are unable to undergo the procedure under local anesthesia or fail to follow post-operative instructions.
- Patients who withdraw from the study before completion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Children's Hospital 1, Department of Odonto-Stomatology
Ho Chi Minh City
Phung Van Ho, DDS, (+84) 983791484, hvphung.ckii.rhm23@ump.edu.vn
Phung Van Ho, DDS
- Recruiting
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City
Phong Dai Lam, PhD, DDS, (+84) 906312958, phonglam@ump.edu.vn
Phung Van Ho, DDS
About this study
Official title: Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy
This study aims to compare the wound healing efficacy and postoperative experiences between the 940 nm diode laser technique and the traditional electrosurgery method for treating ankyloglossia (tongue-tie) in children aged 3 to 6 years.
Participants are randomly assigned to one of two groups: Experimental Group - Patients undergo lingual frenectomy using a 940 nm diode laser and Active Comparator Group - Patients undergo the procedure using conventional high-frequency electrosurgery.
Read more
The study evaluates several key outcomes at multiple intervals (24 hours, 3 days, 1 week, and 1 month post-surgery), including: (1) Wound Healing: Measured by the Early Wound Healing Score (EHS); (2) Pain Levels: Assessed using the Wong-Baker FACES Pain Rating Scale; (3) Bleeding Control: Evaluation of intraoperative bleeding; (4) Tongue Mobility: Measurement of free tongue length according to Kotlow's classification.
The goal is to determine if the diode laser provides superior healing, less pain, and better bleeding control compared to electrosurgery.
Read the detailed description
Participant Allocation: Participants meeting the inclusion criteria (aged 3-6, diagnosed with Kotlow grade 3 or 4 ankyloglossia) are randomly assigned to one of two groups using a simple randomization method (drawing lots):
- Group 1 (Laser Group): Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase) with a power of 1W (average) and 2W (peak) in pulsed mode (CP2).
- Group 2 (Electrosurgery Group): Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C) in continuous contact mode.
Surgical Procedure: Both groups follow a standardized surgical protocol:
- Anesthesia: Local anesthesia with 2% Lidocaine/Adrenaline (0.45 ml).
- Technique: Transverse incision without suturing or muscle dissection to release the lingual frenum.
- Safety Measures: Use of protective eyewear for the laser group and electrode grounding pads for the electrosurgery group.
Data Collection and Blinding:
- Blinding: This is a single-blind study where the participants and their guardians are unaware of the assigned treatment group. The evaluator measuring post-operative outcomes is also blinded to the surgical method used.
- Follow-up Schedule: Evaluations are conducted at five specific intervals:
- Baseline (T0): Pre-operative measurements.
- Post-operative: At 24 hours (T1), 3 days (T2), 1 week (T3), and 1 month (T4).
Evaluation Criteria:
- Wound Healing: Assessed by the Early Wound Healing Score (EHS), focusing on re-epithelialization (CSR), haemostasis (CSH), and inflammation (CSI).
- Pain Intensity: Self-reported by patients using the Wong-Baker FACES Pain Rating Scale.
- Tongue Function: Measuring the increase in free tongue length (mm) using a Quick Tongue-Tie (QTT) tool.
- Conditions
- Ankyloglossia, Tongue-tie
- Being tested
- Lingual Frenectomy using 940nm Diode Laser, Lingual Frenectomy using High-frequency Electrosurgery
- Keywords
- Ankyloglossia, Tongue-tie, Lingual frenectomy, Diode laser, Electrosurgery, Wound healing, Postoperative pain, Early Wound Healing Score (EHS), Wong-Baker FACES Pain Rating Scale, Kotlow's classification
- Medical subject headings
- Ankyloglossia, Hyperthermia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual Frenectomy using 940nm Diode LaserProcedure or surgery
Also called Diode Laser Frenectomy, Laser-assisted Frenotomy
Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase). The laser is set to pulsed mode (CP2), average power 1W, and peak power 2W. The procedure involves a transverse incision to release the frenum without suturing. Protective eyewear is mandatory for the patient and surgical team.
Lingual Frenectomy using High-frequency ElectrosurgeryProcedure or surgery
Also called Electrosurgical Frenectomy, Electrocautery Frenotomy
Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows a standardized transverse incision protocol without suturing. A grounding pad (electrode) is applied to the patient's body to complete the circuit. This serves as the active comparator representing the conventional surgical method at the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Diode Laser Group | Experimental | Patients in this group undergo lingual frenectomy using a 940 nm diode laser (Epic X, Biolase). The procedure is performed using a transverse incision technique without suturing. Laser settings include an average power of 1W, peak power of 2W in pulsed mode (CP2), and a 940 nm wavelength. Receives: Procedure: Lingual Frenectomy using 940nm Diode Laser |
| Electrosurgery Group | Active comparator | Patients in this group undergo lingual frenectomy using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows the same transverse incision protocol without suturing as the experimental group. Receives: Procedure: Lingual Frenectomy using High-frequency Electrosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Wound Healing Score (EHS)
The EHS is used to evaluate the early healing of periodontal soft tissue wounds. It is the sum of three components: Clinical Signs of Re-epithelialization (CSR), Clinical Signs of Haemostasis (CSH), and Clinical Signs of Inflammation (CSI). The total score ranges from 0 to 10, where a higher score indicates better and faster wound healing (10 being perfect healing).
Measured: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
Secondary outcomes (3)
Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale
Patients self-assess their pain levels using a scale of 6 faces representing different pain intensities. Scores range from 0 (no pain) to 10 (worst possible pain), with increments of 2 (0, 2, 4, 6, 8, 10).
Measured: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
Level of Intraoperative Bleeding
Bleeding is assessed during the surgical procedure and categorized into 2 levels: Grade 1 (No bleeding) and Grade 2 (Bleeding present, requiring local haemostatic measures like gauze pressure or laser/electrosurgery coagulation).
Measured: During the surgical procedure (T0)
Increase in Free Tongue Length
Measured as the distance (in mm) from the attachment of the lingual frenum on the ventral surface of the tongue to the tip of the tongue using a Quick Tongue-Tie (QTT) measurement tool.
Measured: Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnkyloglossiaStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- The study utilizes a parallel-group, randomized clinical trial design with a 1:1 allocation ratio. Participants are assigned to either the experimental group or the control group using a simple randomization method (drawing lots). * Randomization: A total of 50 lots are prepared, divided into two equal sets marked with numbers "1" and "2". Each participant draws one lot to determine their treatment group. * Allocation: Group 1 (Experimental): Participants who draw lot "1" undergo lingual frenectomy using a 940 nm diode laser. Group 2 (Control): Participants who draw lot "2" undergo the procedure using high-frequency electrosurgery. * Blinding: This is a single-blind study. Participants and their legal guardians are blinded to the assigned surgical method. To ensure objective results, the outcome evaluator is also blinded to the participant's treatment group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phong Dai Lam, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557875
- Sponsor's protocol ID
- IRB00010293-2026
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared to ensure absolute confidentiality for the pediatric patients and their families, as stated in the informed consent and study protocol approved by the Ethics Committee.
Publications
Kotlow LA. Ankyloglossia (tongue-tie): a diagnostic and treatment quandary. Quintessence Int. 1999 Apr;30(4):259-62.
PubMed 10635253Hwang WB, Kim DJ, Oh GS, Park JH. Aryl Hydrocarbon Receptor Ligands Indoxyl 3-sulfate and Indole-3-carbinol Inhibit FMS-like Tyrosine Kinase 3 Ligand-induced Bone Marrow-derived plasmacytoid Dendritic Cell Differentiation. Immune Netw. 2018 Oct 23;18(5):e35. doi: 10.4110/in.2018.18.e35. eCollection 2018 Oct.
PubMed 30402330Mazzoni A, Navarro RS, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT, Silva T, Santos EM, Sobral APT, Junior AB, Nammour S, Motta LJ, Bussadori SK. Comparison of the Effects of High-Power Diode Laser and Electrocautery for Lingual Frenectomy in Infants: A Blinded Randomized Controlled Clinical Trial. J Clin Med. 2022 Jun 30;11(13):3783. doi: 10.3390/jcm11133783.
PubMed 35807068
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy
- ClinicalTrials.gov ID
- NCT07557875
- Acronym / sponsor ID
- IRB00010293-2026
- Conditions
- Ankyloglossia, Tongue-tie
- Keywords
- Ankyloglossia, Tongue-tie, Lingual frenectomy, Diode laser, Electrosurgery, Wound healing, Postoperative pain, Early Wound Healing Score (EHS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 30 Apr 2026 (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.
This study aims to compare the wound healing efficacy and postoperative experiences between the 940 nm diode laser technique and the traditional electrosurgery method for treating ankyloglossia (tongue-tie) in children aged 3 to 6 years.
Participants are randomly assigned to one of two groups: Experimental Group - Patients undergo lingual frenectomy using a 940 nm diode laser and Active Comparator Group - Patients undergo the procedure using conventional high-frequency electrosurgery.
The study evaluates several key outcomes at multiple intervals (24 hours, 3 days, 1 week, and 1 month post-surgery), including: (1) Wound Healing: Measured by the Early Wound Healing Score (EHS); (2) Pain Levels: Assessed using the Wong-Baker FACES Pain Rating Scale; (3) Bleeding Control: Evaluation of intraoperative bleeding; (4) Tongue Mobility: Measurement of free tongue length according to Kotlow's classification.
The goal is to determine if the diode laser provides superior healing, less pain, and better bleeding control compared to electrosurgery.
Detailed description
Participant Allocation: Participants meeting the inclusion criteria (aged 3-6, diagnosed with Kotlow grade 3 or 4 ankyloglossia) are randomly assigned to one of two groups using a simple randomization method (drawing lots):
- Group 1 (Laser Group): Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase) with a power of 1W (average) and 2W (peak) in pulsed mode (CP2).
- Group 2 (Electrosurgery Group): Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C) in continuous contact mode.
Surgical Procedure: Both groups follow a standardized surgical protocol:
- Anesthesia: Local anesthesia with 2% Lidocaine/Adrenaline (0.45 ml).
- Technique: Transverse incision without suturing or muscle dissection to release the lingual frenum.
- Safety Measures: Use of protective eyewear for the laser group and electrode grounding pads for the electrosurgery group.
Data Collection and Blinding:
- Blinding: This is a single-blind study where the participants and their guardians are unaware of the assigned treatment group. The evaluator measuring post-operative outcomes is also blinded to the surgical method used.
- Follow-up Schedule: Evaluations are conducted at five specific intervals:
- Baseline (T0): Pre-operative measurements.
- Post-operative: At 24 hours (T1), 3 days (T2), 1 week (T3), and 1 month (T4).
Evaluation Criteria:
- Wound Healing: Assessed by the Early Wound Healing Score (EHS), focusing on re-epithelialization (CSR), haemostasis (CSH), and inflammation (CSI).
- Pain Intensity: Self-reported by patients using the Wong-Baker FACES Pain Rating Scale.
- Tongue Function: Measuring the increase in free tongue length (mm) using a Quick Tongue-Tie (QTT) tool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study utilizes a parallel-group, randomized clinical trial design with a 1:1 allocation ratio. Participants are assigned to either the experimental group or the control group using a simple randomization method (drawing lots). * Randomization: A total of 50 lots are prepared, divided into two equal sets marked with numbers "1" and "2". Each participant draws one lot to determine their treatment group. * Allocation: Group 1 (Experimental): Participants who draw lot "1" undergo lingual frenectomy using a 940 nm diode laser. Group 2 (Control): Participants who draw lot "2" undergo the procedure using high-frequency electrosurgery. * Blinding: This is a single-blind study. Participants and their legal guardians are blinded to the assigned surgical method. To ensure objective results, the outcome evaluator is also blinded to the participant's treatment group.
| Arm | Type | Receives |
|---|---|---|
| Diode Laser Group | Experimental | Procedure: Lingual Frenectomy using 940nm Diode LaserPatients in this group undergo lingual frenectomy using a 940 nm diode laser (Epic X, Biolase). The procedure is performed using a transverse incision technique without suturing. Laser settings include an average power of 1W, peak power of 2W in pulsed mode (CP2), and a 940 nm wavelength. |
| Electrosurgery Group | Active comparator | Procedure: Lingual Frenectomy using High-frequency ElectrosurgeryPatients in this group undergo lingual frenectomy using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows the same transverse incision protocol without suturing as the experimental group. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients aged between 3 and 6 years.
- Diagnosed with grade 3 or grade 4 ankyloglossia according to Kotlow's classification (1999).
- Parents or legal guardians provide informed consent for the child to participate in the study.
- Patients and guardians agree to follow the follow-up schedule (24 hours, 3 days, 1 week, and 1 month post-surgery).
Key exclusion criteria (4 listed)
- History of allergy to local anesthetics (e.g., Lidocaine, Adrenaline).
- Patients with systemic diseases or high-risk surgical factors (e.g., cardiovascular disease, bleeding disorders, hemophilia, epilepsy, or uncontrolled asthma).
- Uncooperative patients who are unable to undergo the procedure under local anesthesia or fail to follow post-operative instructions.
- Patients who withdraw from the study before completion.
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 |
|---|---|---|
| Lingual Frenectomy using 940nm Diode LaserAlso: Diode Laser Frenectomy, Laser-assisted FrenotomyLingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase). The laser is set to pulsed mode (CP2), average power 1W, and peak power 2W. The procedure involves a transverse incision to release the frenum without suturing. Protective eyewear is mandatory for the patient and surgical team. | Procedure or surgery | Diode Laser Group |
| Lingual Frenectomy using High-frequency ElectrosurgeryAlso: Electrosurgical Frenectomy, Electrocautery FrenotomyLingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows a standardized transverse incision protocol without suturing. A grounding pad (electrode) is applied to the patient's body to complete the circuit. This serves as the active comparator representing the conventional surgical method at the hospital. | Procedure or surgery | Electrosurgery Group |
Primary outcome
Early Wound Healing Score (EHS)
Time frame: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
The EHS is used to evaluate the early healing of periodontal soft tissue wounds. It is the sum of three components: Clinical Signs of Re-epithelialization (CSR), Clinical Signs of Haemostasis (CSH), and Clinical Signs of Inflammation (CSI). The total score ranges from 0 to 10, where a higher score indicates better and faster wound healing (10 being perfect healing).
3 secondary outcomes
Pain Intensity assessed by Wong-Baker FACES Pain Rating Scale
Time frame: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.
Level of Intraoperative Bleeding
Time frame: During the surgical procedure (T0)
Increase in Free Tongue Length
Time frame: Baseline (T0), 1 week (T3), and 1 month (T4) post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 10635253Kotlow LA. Ankyloglossia (tongue-tie): a diagnostic and treatment quandary. Quintessence Int. 1999 Apr;30(4):259-62.
- Background: PubMed 30402330Hwang WB, Kim DJ, Oh GS, Park JH. Aryl Hydrocarbon Receptor Ligands Indoxyl 3-sulfate and Indole-3-carbinol Inhibit FMS-like Tyrosine Kinase 3 Ligand-induced Bone Marrow-derived plasmacytoid Dendritic Cell Differentiation. Immune Netw. 2018 Oct 23;18(5):e35. doi: 10.4110/in.2018.18.e35. eCollection 2018 Oct.
- Background: PubMed 35807068Mazzoni A, Navarro RS, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT, Silva T, Santos EM, Sobral APT, Junior AB, Nammour S, Motta LJ, Bussadori SK. Comparison of the Effects of High-Power Diode Laser and Electrocautery for Lingual Frenectomy in Infants: A Blinded Randomized Controlled Clinical Trial. J Clin Med. 2022 Jun 30;11(13):3783. doi: 10.3390/jcm11133783.
- University of Medicine and Pharmacy at Ho Chi Minh City - Faculty of DentistryLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individual participant data will not be shared to ensure absolute confidentiality for the pediatric patients and their families, as stated in the informed consent and study protocol approved by the Ethics Committee.
Related trials for Ankyloglossia
Recruiting
Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
Ankyloglossia, Impairment of Speech
Enrolling by invitationObservational study
Long-term Follow-up of Infant Frenotomy/Frenectomy Through Early Childhood
Ankyloglossia
Not yet recruiting
SNIP follow-on Case Series Using v3 Device
Ankyloglossia
Not yet recruitingObservational study
Ankyloglossia and Breastfeeding
Ankyloglossia, Breastfeeding
Recruiting
The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes
Ankyloglossia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lingual Frenectomy using 940nm Diode Laser and Lingual Frenectomy using High-frequency Electrosurgery in people with Ankyloglossia and Tongue-tie, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phong Dai Lam, PhD, DDS ((+84) 906312958, phonglam@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Wound Healing Score (EHS) (time frame: 24 hours (T1), 3 days (T2), and 1 week (T3) post-surgery.). 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 NCT07557875, which also lists 3 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 30 Apr 2026.