FrenulectomyNCT07773701
Effects of Epithelialization-enhancing Agents Following Diode Laser-assisted Frenectomy: A Randomized Clinical Trial
A study testing Hyaluronic Acid Gel (Gengigel®) and Bioactive Micronutrient Gel (Miradont®-Gel) in people with Frenulectomy, run by University of Zagreb at 1 site in Croatia.
Trial summary
The purpose of this randomized clinical trial is to evaluate and compare the effects of two topical epithelialization-enhancing agents-a hyaluronic acid-based gel (Gengigel®) and a bioactive micronutrient-based gel (Miradont®-Gel)-versus no topical agent (control) on soft tissue wound healing following diode… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Frenulectomy
- What is being tested?
- Hyaluronic Acid Gel (Gengigel®) and Bioactive Micronutrient Gel (Miradont®-Gel)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCroatia
- Study dates
- 6 Feb 2023to 25 Jan 2024
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 7 and 18 years
- Low insertion / attachment of the maxillary labial frenum requiring surgical excision
- Presence of maxillary midline diastema associated with the frenum
- Complete eruption of permanent maxillary central incisors
- Good systemic health
- Good oral health
- Written informed consent signed by the patient and/or parent/legal guardian prior to enrollment
Who cannot join
- Incomplete eruption of permanent maxillary central incisors
- Presence of systemic diseases or medical conditions that could interfere with wound healing or bone/soft tissue metabolism
- Active oral infections, extensive untreated caries, or poor periodontal status
- Known hypersensitivity or allergy to local anesthetics, hyaluronic acid, or any ingredients of the study gels (Miradont®-Gel or Gengigel®)
- History of previous surgical intervention in the maxillary labial frenum area
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized clinical trial is to evaluate and compare the effects of two topical epithelialization-enhancing agents-a hyaluronic acid-based gel (Gengigel®) and a bioactive micronutrient-based gel (Miradont®-Gel)-versus no topical agent (control) on soft tissue wound healing following diode laser-assisted maxillary labial frenectomy. Pediatric and adolescent patients requiring maxillary labial frenectomy are randomly assigned into three parallel groups:Control Group: Diode laser frenectomy without topical agent application. Miradont® Group: Diode laser frenectomy followed by postoperative application of Miradont®-Gel three times daily for 14 days. Gengigel® Group: Diode laser frenectomy followed by postoperative application of Gengigel® three times daily for 14 days. Postoperative wound healing, re-epithelialization, and cellular maturation are evaluated clinically and cytologically on days 3, 7, and 14 following the surgical intervention.
Read the detailed description
Diode lasers are widely utilized in soft tissue oral surgery due to their precise cutting, intraoperative decontamination, and minimal bleeding; however, thermal damage can sometimes lead to delayed secondary-intention epithelialization. This randomized clinical study investigates whether adjunctive topical application of hyaluronic acid gel or micronutrient gel accelerates mucosal regeneration and reduces inflammatory response following high-power diode laser frenectomy (975 nm, 4W). Clinical parameters (hyperemia, edema, bleeding, fibrinous adhesion) and semi-quantitative cytological markers (granulocytes, erythrocytes, epithelial cells, stromal cells, and Maturation Index) are longitudinally analyzed at Days 3, 7, and 14 post-intervention.
- Conditions
- Frenulectomy
- Being tested
- Hyaluronic Acid Gel (Gengigel®), Bioactive Micronutrient Gel (Miradont®-Gel)
- Keywords
- lasers, oral frenectomy, epithelization, hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid Gel (Gengigel®)Device
Topical application of hyaluronic acid gel (approx. 0.5 ml) directly to the laser surgical wound three times daily (after meals and before sleep) for 14 consecutive days.
Bioactive Micronutrient Gel (Miradont®-Gel)Device
opical application of bioactive micronutrient gel containing vitamins and minerals (approx. 0.5 ml) directly to the laser surgical wound three times daily (after meals and before sleep) for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients undergo diode laser-assisted maxillary labial frenectomy without the postoperative application of any topical epithelialization-enhancing agent. |
| Miradont-Gel Group | Experimental | Patients undergo diode laser-assisted maxillary labial frenectomy followed by topical application of Miradont®-Gel (approx. 0.5 ml) to the surgical site three times daily for 14 days. Receives: Device: Bioactive Micronutrient Gel (Miradont®-Gel) |
| Gengigel Group | Experimental | Patients undergo diode laser-assisted maxillary labial frenectomy followed by topical application of Gengigel® (hyaluronic acid gel, approx. 0.5 ml) to the surgical site three times daily for 14 days. Receives: Device: Hyaluronic Acid Gel (Gengigel®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelial Maturation Index (MI)
Quantitative assessment of mucosal epithelial differentiation and cellular maturation evaluated by cytological smears from the surgical wound using the standardized Frost method. The index calculates the percentage distribution of basal, parabasal, intermediate, and superficial epithelial cells to determine the degree of tissue regeneration.
Measured: Day 3, Day 7, and Day 14 post-intervention
Secondary outcomes (4)
Inflammatory Response (Granulocyte Presence Score)
Semi-quantitative cytological assessment of inflammatory infiltrate in wound smears, scored on a 4-point scale: 0 = absence of granulocytes / clean background; 1 = low presence (≤ 2); 2 = moderate presence (2 < n ≤ 5); 3 = significant presence with tissue detritus (> 5). Lower scores indicate faster resolution of inflammation.
Measured: Day 3, Day 7, and Day 14 post-intervention
Re-Epithelialization
Semi-quantitative cytological score evaluating the density of epithelial cells in wound smears on a 4-point scale: 0 = absence/minimal presence; 1 = low presence (≤ 2); 2 = moderate presence (2 < n ≤ 5); 3 = satisfactory presence (> 5). Higher scores indicate advanced re-epithelialization.
Measured: Day 3, Day 7, and Day 14 post-intervention
Clinical Wound Healing and Complications
Clinical evaluation of secondary-intention wound healing at the surgical site, recording the presence or absence of postoperative hyperemia, edema, postoperative bleeding, and fibrinous deposition.
Measured: Day 3, Day 7, and Day 14 post-intervention
Preoperative Patient Fear Score
Patient-reported subjective fear and anxiety assessed prior to the procedure using a Visual Analogue Scale (VAS) ranging from 0 (no fear) to 10 (extreme fear), categorized into low (0-3), moderate (4-6), and strong fear (7-10).
Measured: Immediately prior to surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start6 Feb 2023
- Primary completion5 Dec 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrenulectomyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Ss. Cyril and Methodius University of Skopje
- Responsible party
- Principal investigator, Roko Bjelica, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773701
- Sponsor's protocol ID
- 02-996/3
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Epithelialization-enhancing Agents Following Diode Laser-assisted Frenectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07773701
- Acronym / sponsor ID
- 02-996/3
- Conditions
- Frenulectomy
- Keywords
- lasers, oral frenectomy, epithelization, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- Ss. Cyril and Methodius University of Skopje
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 19 Aug 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.
The purpose of this randomized clinical trial is to evaluate and compare the effects of two topical epithelialization-enhancing agents-a hyaluronic acid-based gel (Gengigel®) and a bioactive micronutrient-based gel (Miradont®-Gel)-versus no topical agent (control) on soft tissue wound healing following diode laser-assisted maxillary labial frenectomy. Pediatric and adolescent patients requiring maxillary labial frenectomy are randomly assigned into three parallel groups:Control Group: Diode laser frenectomy without topical agent application. Miradont® Group: Diode laser frenectomy followed by postoperative application of Miradont®-Gel three times daily for 14 days. Gengigel® Group: Diode laser frenectomy followed by postoperative application of Gengigel® three times daily for 14 days. Postoperative wound healing, re-epithelialization, and cellular maturation are evaluated clinically and cytologically on days 3, 7, and 14 following the surgical intervention.
Detailed description
Diode lasers are widely utilized in soft tissue oral surgery due to their precise cutting, intraoperative decontamination, and minimal bleeding; however, thermal damage can sometimes lead to delayed secondary-intention epithelialization. This randomized clinical study investigates whether adjunctive topical application of hyaluronic acid gel or micronutrient gel accelerates mucosal regeneration and reduces inflammatory response following high-power diode laser frenectomy (975 nm, 4W). Clinical parameters (hyperemia, edema, bleeding, fibrinous adhesion) and semi-quantitative cytological markers (granulocytes, erythrocytes, epithelial cells, stromal cells, and Maturation Index) are longitudinally analyzed at Days 3, 7, and 14 post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients undergo diode laser-assisted maxillary labial frenectomy without the postoperative application of any topical epithelialization-enhancing agent. |
| Miradont-Gel Group | Experimental | Device: Bioactive Micronutrient Gel (Miradont®-Gel)Patients undergo diode laser-assisted maxillary labial frenectomy followed by topical application of Miradont®-Gel (approx. 0.5 ml) to the surgical site three times daily for 14 days. |
| Gengigel Group | Experimental | Device: Hyaluronic Acid Gel (Gengigel®)Patients undergo diode laser-assisted maxillary labial frenectomy followed by topical application of Gengigel® (hyaluronic acid gel, approx. 0.5 ml) to the surgical site three times daily for 14 days. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age between 7 and 18 years
- Low insertion / attachment of the maxillary labial frenum requiring surgical excision
- Presence of maxillary midline diastema associated with the frenum
- Complete eruption of permanent maxillary central incisors
- Good systemic health
Key exclusion criteria (5 listed)
- Incomplete eruption of permanent maxillary central incisors
- Presence of systemic diseases or medical conditions that could interfere with wound healing or bone/soft tissue metabolism
- Active oral infections, extensive untreated caries, or poor periodontal status
- Known hypersensitivity or allergy to local anesthetics, hyaluronic acid, or any ingredients of the study gels (Miradont®-Gel or Gengigel®)
- History of previous surgical intervention in the maxillary labial frenum area
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 |
|---|---|---|
| Hyaluronic Acid Gel (Gengigel®)Topical application of hyaluronic acid gel (approx. 0.5 ml) directly to the laser surgical wound three times daily (after meals and before sleep) for 14 consecutive days. | Device | Gengigel Group |
| Bioactive Micronutrient Gel (Miradont®-Gel)opical application of bioactive micronutrient gel containing vitamins and minerals (approx. 0.5 ml) directly to the laser surgical wound three times daily (after meals and before sleep) for 14 consecutive days. | Device | Miradont-Gel Group |
Primary outcome
Epithelial Maturation Index (MI)
Time frame: Day 3, Day 7, and Day 14 post-intervention
Quantitative assessment of mucosal epithelial differentiation and cellular maturation evaluated by cytological smears from the surgical wound using the standardized Frost method. The index calculates the percentage distribution of basal, parabasal, intermediate, and superficial epithelial cells to determine the degree of tissue regeneration.
4 secondary outcomes
Inflammatory Response (Granulocyte Presence Score)
Time frame: Day 3, Day 7, and Day 14 post-intervention
Re-Epithelialization
Time frame: Day 3, Day 7, and Day 14 post-intervention
Clinical Wound Healing and Complications
Time frame: Day 3, Day 7, and Day 14 post-intervention
Preoperative Patient Fear Score
Time frame: Immediately prior to surgical intervention
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 19 Aug 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid Gel (Gengigel®) and Bioactive Micronutrient Gel (Miradont®-Gel) in people with Frenulectomy, run by University of Zagreb at 1 site in Croatia.
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 7 inclusion and 5 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 19 Aug 2026. 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 Croatia. 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?
Epithelial Maturation Index (MI) (time frame: Day 3, Day 7, and Day 14 post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.