Post-surgical Oral WoundsPR-DENTNCT07421934
Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.
A study testing Intervention: Linear Hyaluronic Acid (Gumblast) in people with Post-surgical Oral Wounds and Oral Cavity Surgery, run by The Wave Innovation Group s.r.l. at 1 site in Italy.
Trial summary
The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of oral surgical wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-surgical Oral Wounds, Oral Cavity Surgery, Wound Healing/Regeneration
- What is being tested?
- Intervention: Linear Hyaluronic Acid (Gumblast)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 29 Oct 2024to 31 Dec 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
- Adult patients requiring extractive surgery in at least two different sites , with a good state of oral and systemic health.
- Subjects capable of complying with the study protocol procedures.
- Provision of a signed Informed Consent form.
Who cannot join
- Patients with a history of alcoholism.
- Smokers of more than 10 cigarettes per day.
- Patients who have undergone radiotherapy, chemotherapy, or immunosuppressive therapy within the last five years.
- Patients who have undergone antibiotic therapy within the last two months.
- Patients on bisphosphonate therapy.
- Patients with poor oral hygiene, an acute infection at the treatment site, or any contraindications to extractive surgery.
- Allergies to local anesthetics.
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento Multidisciplinare di Specialità Medico-Chirurgiche e Odontoiatriche - Via Luigi De Crecchio,6 , 80138 NAPOLI
Naples, 80138
About this study
The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of oral surgical wounds.
The investigational device consists of high molecular weight sodium hyaluronate (2500-3500 kDa), obtained through bacterial fermentation, combined with amino acids (L-proline, L-hydroxyproline, glycine, and L-lysine HCl), formulated at a concentration of 25 mg/ml. The device is designed to promote wound healing through the hydrating and film-forming properties of hyaluronic acid, creating a favorable microenvironment for re-epithelialization and tissue regeneration.
Read more
The study is sponsored by The Wave Innovation Srl and conducted at the Oral Surgery and Stomatology Unit of the Azienda Ospedaliera Universitaria Luigi Vanvitelli, under the scientific responsibility of Prof. Luigi Laino. No additional costs are foreseen for the National Health Service, and no compensation is provided to investigators.
The primary objective of the study is to assess the safety and clinical performance of the device in improving the healing of post-surgical oral wounds. The main outcomes include improvement in the Clinical Healing Score (CHS)-a clinical score assessing redness, edema, suppuration, healthy granulation tissue, and signs of re-epithelialization-the rate of wound closure evaluated through morphometric analysis, and the incidence of adverse events.
The study population consists of adult patients requiring extraction of at least two teeth. For each patient, two surgical sites are identified: one treated with the hyaluronic acid-based device and one serving as an internal control, allowing for direct intra-patient comparison. The device is injected into the post-extraction socket prior to suturing or applied to the adjacent soft tissues.
The study design includes a screening visit (Visit 0), a surgical treatment visit (Visit 1), and three follow-up visits at 7, 14, and 30 days after treatment completion (Visits 2, 3, and 4). During follow-up visits, the Clinical Healing Score, wound closure via morphometric analysis, and the occurrence of any adverse events are assessed.
Inclusion criteria include adult patients in good systemic and oral health, able to comply with study procedures, and who have provided written informed consent. Exclusion criteria include factors that may interfere with wound healing, such as smoking more than 10 cigarettes per day, recent oncological therapies, recent antibiotic therapy, bisphosphonate treatment, pregnancy or breastfeeding, and acute infection at the surgical site.
Safety is evaluated through the recording and classification of all adverse events (AEs) and serious adverse events (SAEs), in accordance with applicable regulations and Good Clinical Practice (ISO 14155). Risks associated with the use of the device are considered minimal and mainly related to the surgical procedure itself. Based on extensive scientific literature supporting the use of hyaluronic acid in oral wound healing, the overall risk-benefit profile is considered favorable.
The study is conducted in compliance with the principles of the Declaration of Helsinki, Good Clinical Practice, and Regulation (EU) 2017/745 on medical devices.
- Conditions
- Post-surgical Oral Wounds, Oral Cavity Surgery, Wound Healing/Regeneration, Dental Extraction Sites, Alveolar Socket Recovery, Post-extractive Inflammation
- Being tested
- Intervention: Linear Hyaluronic Acid (Gumblast), Control: Standard Surgical Procedure
- Keywords
- Interventional, monocentric, controlled trial, Medical Device Class III, Linear Hyaluronic Acid (HA), Amino Acid complex (L-proline, L-hydroxyproline, Glycine, L-lysine), Split-mouth design (one treated site vs one internal control site, Oral surgery and post-surgical wounds, Tooth extraction (impacted third molar), Wound healing acceleration, Clinical Healing Score (CHS), Morphometric analysis of oral mucosa, Post-extractive alveolar socket treatment, High molecular weight sodium hyaluronate (2500-3500 Kd)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Linear Hyaluronic Acid (Gumblast)Procedure or surgery
Combined Ingredients: Unlike many standalone hyaluronic acid (HA) treatments, this intervention uses a specific complex of high molecular weight linear HA (25 mg/ml) combined with a precise pool of four amino acids: L-proline, L-hydroxyproline, Glycine, and L-lysine HCl.
Specific HA Molecular Weight: The sodium hyaluronate used has a high molecular weight range of 2500-3500 Kd, produced specifically from Streptococcus equi bacteria.
Class III Classification: The device is classified under Class III (EU 2017/745), emphasizing its biological effect and absorption characteristics within the human body.
Specific Delivery and Surgical Application:
Intra-Operative Timing: The device is not just a topical post-operative gel; it is specifically injected into the surgical wound or applied to the soft tissues before suturing.
Versatile Delivery Tools: The protocol allows for the use of both pointed or blunt needles applied to a 2 ml pre-filled syringe.
Control: Standard Surgical ProcedureProcedure or surgery
Intervention Type: Other (Standard Care/Sham).
Description: This arm consists of the second surgical site (post-extractive alveolar socket) within the same patient that does not receive the study device.
Procedure: The site undergoes the identical standard surgical extraction protocol as the experimental site but is sutured without the injection or application of the hyaluronic acid-based gel.
Objective: To serve as an internal baseline control for assessing the natural healing process and to compare the safety and performance outcomes (Clinical Healing Score and morphometric analysis) against the experimental intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Linear Hyaluronic Acid | Experimental | Description: Participants in this arm receive a single injection of a Class III medical device composed of high molecular weight linear hyaluronic acid (25 mg/ml) and a specific complex of amino acids (L-proline, L-hydroxyproline, Glycine, L-lysine HCl).
Procedure: The gel is administered directly into the post-extractive alveolar socket or applied to the adjacent soft tissues immediately following the surgical extraction of a dental element and prior to wound suturing.
Dosage: The device is supplied in a 2 ml pre-filled sterile syringe.
Objective: The intervention is intended to create a favorable microenvironment for healing, providing a hydrating film that protects the tissue and promotes rapid re-epithelialization and wound closure. Receives: Procedure: Intervention: Linear Hyaluronic Acid (Gumblast) |
| Control: Standard Surgical Procedure | Sham comparator | Description: This arm consists of the second surgical site (post-extractive alveolar socket) within the same patient that does not receive the study device.
Procedure: The site undergoes the identical standard surgical extraction protocol as the experimental site but is sutured without the injection or application of the hyaluronic acid-based gel.
Objective: To serve as an internal baseline control for assessing the natural healing process and to compare the safety and performance outcomes (Clinical Healing Score and morphometric analysis) against the experimental intervention. Receives: Procedure: Control: Standard Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Clinical Healing Score (CHS)
The Clinical Healing Score is a clinician-reported assessment used to evaluate the quality of wound healing on a scale from 1 to 5.
5 (Excellent): All wound area is pink; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin.
4 (Very Good): Less than one quarter of wound area is red; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin.
3 (Good): Less than half of the wound area is red; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin.
2 (Poor): More than half of the wound area is red; bleeding on palpation; granulation tissue evident; incision margin not epithelialized.
1 (Very Poor): Two or more features present, such as more than half of the wound area being red, bleeding on palpation, evident granulation tissue, no epithelium at incision margin, or infection with suppuration.
Measured: 7 days after the surgical treatment (Visit 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start29 Oct 2024
- Primary completion10 Nov 2024
- Study completion31 Dec 2025
Why it stopped: We agreed with the sponsor that the recruitment of 28 subjects would already be sufficient to obtain statistically significant results. For this reason, we submitted an amendment to the Ethics Committee.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgical Oral WoundsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Wave Innovation Group s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421934
- Sponsor's protocol ID
- CIP-01-23
- Acronym
- PR-DENT
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.
- ClinicalTrials.gov ID
- NCT07421934
- Acronym / sponsor ID
- PR-DENT / CIP-01-23
- Conditions
- Post-surgical Oral Wounds, Oral Cavity Surgery, Wound Healing/Regeneration, Dental Extraction Sites, Alveolar Socket Recovery, Post-extractive Inflammation
- Keywords
- Interventional, monocentric, controlled trial, Medical Device Class III, Linear Hyaluronic Acid (HA), Amino Acid complex (L-proline, L-hydroxyproline, Glycine, L-lysine), Split-mouth design (one treated site vs one internal control site, Oral surgery and post-surgical wounds, Tooth extraction (impacted third molar), Wound healing acceleration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We agreed with the sponsor that the recruitment of 28 subjects would already be sufficient to obtain statistically significant results. For this reason, we submitted an amendment to the Ethics Committee.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The Wave Innovation Group s.r.l.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Feb 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 PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of oral surgical wounds.
The investigational device consists of high molecular weight sodium hyaluronate (2500-3500 kDa), obtained through bacterial fermentation, combined with amino acids (L-proline, L-hydroxyproline, glycine, and L-lysine HCl), formulated at a concentration of 25 mg/ml. The device is designed to promote wound healing through the hydrating and film-forming properties of hyaluronic acid, creating a favorable microenvironment for re-epithelialization and tissue regeneration.
The study is sponsored by The Wave Innovation Srl and conducted at the Oral Surgery and Stomatology Unit of the Azienda Ospedaliera Universitaria Luigi Vanvitelli, under the scientific responsibility of Prof. Luigi Laino. No additional costs are foreseen for the National Health Service, and no compensation is provided to investigators.
The primary objective of the study is to assess the safety and clinical performance of the device in improving the healing of post-surgical oral wounds. The main outcomes include improvement in the Clinical Healing Score (CHS)-a clinical score assessing redness, edema, suppuration, healthy granulation tissue, and signs of re-epithelialization-the rate of wound closure evaluated through morphometric analysis, and the incidence of adverse events.
The study population consists of adult patients requiring extraction of at least two teeth. For each patient, two surgical sites are identified: one treated with the hyaluronic acid-based device and one serving as an internal control, allowing for direct intra-patient comparison. The device is injected into the post-extraction socket prior to suturing or applied to the adjacent soft tissues.
The study design includes a screening visit (Visit 0), a surgical treatment visit (Visit 1), and three follow-up visits at 7, 14, and 30 days after treatment completion (Visits 2, 3, and 4). During follow-up visits, the Clinical Healing Score, wound closure via morphometric analysis, and the occurrence of any adverse events are assessed.
Inclusion criteria include adult patients in good systemic and oral health, able to comply with study procedures, and who have provided written informed consent. Exclusion criteria include factors that may interfere with wound healing, such as smoking more than 10 cigarettes per day, recent oncological therapies, recent antibiotic therapy, bisphosphonate treatment, pregnancy or breastfeeding, and acute infection at the surgical site.
Safety is evaluated through the recording and classification of all adverse events (AEs) and serious adverse events (SAEs), in accordance with applicable regulations and Good Clinical Practice (ISO 14155). Risks associated with the use of the device are considered minimal and mainly related to the surgical procedure itself. Based on extensive scientific literature supporting the use of hyaluronic acid in oral wound healing, the overall risk-benefit profile is considered favorable.
The study is conducted in compliance with the principles of the Declaration of Helsinki, Good Clinical Practice, and Regulation (EU) 2017/745 on medical devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Linear Hyaluronic Acid | Experimental | Procedure: Intervention: Linear Hyaluronic Acid (Gumblast)Description: Participants in this arm receive a single injection of a Class III medical device composed of high molecular weight linear hyaluronic acid (25 mg/ml) and a specific complex of amino acids (L-proline, L-hydroxyproline, Glycine, L-lysine HCl). Procedure: The gel is administered directly into the post-extractive alveolar socket or applied to the adjacent soft tissues immediately following the surgical extraction of a dental element and prior to wound suturing. Dosage: The device is supplied in a 2 ml pre-filled sterile syringe. Objective: The intervention is intended to create a favorable microenvironment for healing, providing a hydrating film that protects the tissue and promotes rapid re-epithelialization and wound closure. |
| Control: Standard Surgical Procedure | Sham comparator | Procedure: Control: Standard Surgical ProcedureDescription: This arm consists of the second surgical site (post-extractive alveolar socket) within the same patient that does not receive the study device. Procedure: The site undergoes the identical standard surgical extraction protocol as the experimental site but is sutured without the injection or application of the hyaluronic acid-based gel. Objective: To serve as an internal baseline control for assessing the natural healing process and to compare the safety and performance outcomes (Clinical Healing Score and morphometric analysis) against the experimental intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients requiring extractive surgery in at least two different sites , with a good state of oral and systemic health.
- Subjects capable of complying with the study protocol procedures.
- Provision of a signed Informed Consent form.
Key exclusion criteria (8 listed)
- Patients with a history of alcoholism.
- Smokers of more than 10 cigarettes per day.
- Patients who have undergone radiotherapy, chemotherapy, or immunosuppressive therapy within the last five years.
- Patients who have undergone antibiotic therapy within the last two months.
- Patients on bisphosphonate therapy.
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 |
|---|---|---|
| Intervention: Linear Hyaluronic Acid (Gumblast)Combined Ingredients: Unlike many standalone hyaluronic acid (HA) treatments, this intervention uses a specific complex of high molecular weight linear HA (25 mg/ml) combined with a precise pool of four amino acids: L-proline, L-hydroxyproline, Glycine, and L-lysine HCl. Specific HA Molecular Weight: The sodium hyaluronate used has a high molecular weight range of 2500-3500 Kd, produced specifically from Streptococcus equi bacteria. Class III Classification: The device is classified under Class III (EU 2017/745), emphasizing its biological effect and absorption characteristics within the human body. Specific Delivery and Surgical Application: Intra-Operative Timing: The device is not just a topical post-operative gel; it is specifically injected into the surgical wound or applied to the soft tissues before suturing. Versatile Delivery Tools: The protocol allows for the use of both pointed or blunt needles applied to a 2 ml pre-filled syringe. | Procedure or surgery | Experimental: Linear Hyaluronic Acid |
| Control: Standard Surgical ProcedureIntervention Type: Other (Standard Care/Sham). Description: This arm consists of the second surgical site (post-extractive alveolar socket) within the same patient that does not receive the study device. Procedure: The site undergoes the identical standard surgical extraction protocol as the experimental site but is sutured without the injection or application of the hyaluronic acid-based gel. Objective: To serve as an internal baseline control for assessing the natural healing process and to compare the safety and performance outcomes (Clinical Healing Score and morphometric analysis) against the experimental intervention. | Procedure or surgery | Control: Standard Surgical Procedure |
Primary outcome
Improvement in Clinical Healing Score (CHS)
Time frame: 7 days after the surgical treatment (Visit 2).
The Clinical Healing Score is a clinician-reported assessment used to evaluate the quality of wound healing on a scale from 1 to 5. 5 (Excellent): All wound area is pink; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin. 4 (Very Good): Less than one quarter of wound area is red; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin. 3 (Good): Less than half of the wound area is red; no bleeding on palpation; no granulation tissue; no connective tissue at incision margin. 2 (Poor): More than half of the wound area is red; bleeding on palpation; granulation tissue evident; incision margin not epithelialized. 1 (Very Poor): Two or more features present, such as more than half of the wound area being red, bleeding on palpation, evident granulation tissue, no epithelium at incision margin, or infection with suppuration.
Results and safety
The study was stopped early (reason given: We agreed with the sponsor that the recruitment of 28 subjects would already be sufficient to obtain statistically significant results. For this reason, we submitted an amendment to the Ethics Committee.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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 Intervention: Linear Hyaluronic Acid (Gumblast) in people with Post-surgical Oral Wounds and Oral Cavity Surgery, run by The Wave Innovation Group s.r.l. at 1 site in Italy.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 19 Feb 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 Italy. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: We agreed with the sponsor that the recruitment of 28 subjects would already be sufficient to obtain statistically significant results. For this reason, we submitted an amendment to the Ethics Committee.). Results are not available in the source record.
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?
Improvement in Clinical Healing Score (CHS) (time frame: 7 days after the surgical treatment (Visit 2).). 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 Feb 2026.