PeriodontitisNCT05907161
Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy
A study testing SRP+LASER (Dentsply Sirona - SIROLaser Blue), SRP+HA and SRP in people with Periodontitis, run by University of Ljubljana at 1 site in Slovenia.
Trial summary
Periodontal disease is an oral disease characterized by microbially associated, host-mediated inflammation of the periodontium. In the treatment of periodontal disease, conventional periodontal therapy includes both surgical and non-surgical approaches. Non-surgical therapy (i.e. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- SRP+LASER (Dentsply Sirona - SIROLaser Blue), SRP+HA and SRP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSlovenia
- Study dates
- 9 Jun 2023to Feb 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systemically healthy
- nonsmokers
- untreated periodontal disease (stage 3, grade B or C)
- plaque index will not exceed 20%
- at least 20 teeth in oral cavity
Who cannot join
- systemic diseases with impact on periodontal health
- medication with impact on periodontal health
- smokers
- pregnant and lactating women
- patients treated with antibiotics in the last 12 months
- patients who had undergone periodontal treatment in the last year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aleš Fidler, Dr. contact
Slovenia1 site, 1 recruiting
- Recruiting
Univerity Medical Center Ljubljana
Ljubljana, 1000
Eva Skaleric, Dr., 0038615222769, eva.skaleric@gmail.com
About this study
Official title: The Effect of Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy in Patients With Periodontitis
Periodontal disease is an oral disease characterized by microbially associated, host-mediated inflammation of the periodontium. In the treatment of periodontal disease, conventional periodontal therapy includes both surgical and non-surgical approaches. Non-surgical therapy (i.e. scaling and root planing - SRP) remains an essential part of periodontal therapy. Here, diseased root surface debridement utilizing different hand and ultrasonic instrumentation is performed to facilitate periodontal re-attachment and to reduce the bacterial mass in the periodontal pocket.
In the last decade, the use of lasers (light amplification by stimulated emission of radiation) has occupied part of the dialogue within periodontology due to several proposed advantages. In the arena of periodontology, laser use, as an adjunct to non-surgical therapy, was demonstrated to enhance periodontal healing; however, it is still the matter of debate. Among laser applications, low-level laser therapy is recommended for its pain-reducing, woundhealing and anti-inflammatory effects.
Hyaluronic acid is a non-sulfated glycosaminoglycan and a major component of the extracellular matrix. It is found in various body fluids, such as gingival crevicular fluid, saliva, serum and synovial fluid. Anti-inflammatory, anti-edematous and anti-bacterial activities of hyaluronic acid have been investigated in dentistry, specially in periodontology.
Read the detailed description
Each participant will be assigned in one of three groups. In each group there will be 15 participants. Different treatment protocols will be carried in each group as follows: group one (scaling and root planing), group two (scaling and root planing + LASER), group three (scaling and root planing + hyaluronic acid). Under local anesthesia we will perform scaling and root planing of the teeth in two sessions. The procedure be made with the use of ultrasonic (PiezoLED Scaler, KaVo, Biberach, DE) and hand instruments (Gracey, Hu Friedy, Chicago, IL, USA). In group one, only scaling and root planning (SRP) will be made. In group two, the use of a diode laser (Dentsply Sirona - SIROLaser Blue) will be added to the therapy. In group three, after the performance of SRP, a gel containing hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic acid gel) will be applied intrasulcular.
- Conditions
- Periodontitis
- Being tested
- SRP+LASER (Dentsply Sirona - SIROLaser Blue), SRP+HA, SRP
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP+LASER (Dentsply Sirona - SIROLaser Blue)Device
adjunct irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) intrasulcularly to all sites with PD ≥ 4mm
SRP+HADevice
adjunct hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic intrasulcularly to all sites with PD ≥ 4mm
SRPDevice
non-surgical periodontal therapy (SRP) with utrasonic device and curretes
| Study group | Role | What they receive |
|---|---|---|
| SRP | Experimental | The SRP group will receive non-surgical periodontal therapy using an ultrasonic device and curettes in two sessions. Receives: Device: SRP |
| SRP+LASER | Active comparator | The SRP+LASER group will receive non-surgical periodontal therapy using an ultrasonic device and curettes in two sessions. After session 2, irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) will be applied intrasulcular to all sites with PD ≥ 4mm. Receives: Device: SRP+LASER (Dentsply Sirona - SIROLaser Blue) |
| SRP+HA | Active comparator | The SRP+HA group will receive non-surgical periodontal therapy using an ultrasonic device and curettes in two sessions. After session 2, a gel containing hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic acid gel) will be applied intrasulcular to all sites with PD ≥ 4mm. Receives: Device: SRP+HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth reduction
Change in probing pocket depth after treatment
Measured: 3 months, 6 months
Secondary outcomes (3)
Clinical attachment level gain
Change in clinical attachment level after treatment
Measured: 3 months, 6 months
Bleeding on probing percentage reduction
Bleeding after measurement of pocket depth, reduction after treatment
Measured: 3 months, 6 months
Residual diseased site number
No of sites with PD ≥ 4mm and bleeding on probing after treatment
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start9 Jun 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Responsible party
- Sponsor
- Investigators
- Aleš Fidler, Dr., Study director, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907161
- Sponsor's protocol ID
- HA AND LASERS IN PERIO TH
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2023
- Last updated
- 19 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT05907161
- Acronym / sponsor ID
- HA AND LASERS IN PERIO TH
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Jun 2023 (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.
Periodontal disease is an oral disease characterized by microbially associated, host-mediated inflammation of the periodontium. In the treatment of periodontal disease, conventional periodontal therapy includes both surgical and non-surgical approaches. Non-surgical therapy (i.e. scaling and root planing - SRP) remains an essential part of periodontal therapy. Here, diseased root surface debridement utilizing different hand and ultrasonic instrumentation is performed to facilitate periodontal re-attachment and to reduce the bacterial mass in the periodontal pocket.
In the last decade, the use of lasers (light amplification by stimulated emission of radiation) has occupied part of the dialogue within periodontology due to several proposed advantages. In the arena of periodontology, laser use, as an adjunct to non-surgical therapy, was demonstrated to enhance periodontal healing; however, it is still the matter of debate. Among laser applications, low-level laser therapy is recommended for its pain-reducing, woundhealing and anti-inflammatory effects.
Hyaluronic acid is a non-sulfated glycosaminoglycan and a major component of the extracellular matrix. It is found in various body fluids, such as gingival crevicular fluid, saliva, serum and synovial fluid. Anti-inflammatory, anti-edematous and anti-bacterial activities of hyaluronic acid have been investigated in dentistry, specially in periodontology.
Detailed description
Each participant will be assigned in one of three groups. In each group there will be 15 participants. Different treatment protocols will be carried in each group as follows: group one (scaling and root planing), group two (scaling and root planing + LASER), group three (scaling and root planing + hyaluronic acid). Under local anesthesia we will perform scaling and root planing of the teeth in two sessions. The procedure be made with the use of ultrasonic (PiezoLED Scaler, KaVo, Biberach, DE) and hand instruments (Gracey, Hu Friedy, Chicago, IL, USA). In group one, only scaling and root planning (SRP) will be made. In group two, the use of a diode laser (Dentsply Sirona - SIROLaser Blue) will be added to the therapy. In group three, after the performance of SRP, a gel containing hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic acid gel) will be applied intrasulcular.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SRP | Experimental | Device: SRPThe SRP group will receive non-surgical periodontal therapy using an ultrasonic device and curettes in two sessions. |
| SRP+LASER | Active comparator | Device: SRP+LASER (Dentsply Sirona - SIROLaser Blue)The SRP+LASER group will receive non-surgical periodontal therapy using an ultrasonic device and curettes in two sessions. After session 2, irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) will be applied intrasulcular to all sites with PD ≥ 4mm. |
| SRP+HA | Active comparator | Device: SRP+HAThe SRP+HA group will receive non-surgical periodontal therapy using an ultrasonic device and curettes in two sessions. After session 2, a gel containing hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic acid gel) will be applied intrasulcular to all sites with PD ≥ 4mm. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- systemically healthy
- nonsmokers
- untreated periodontal disease (stage 3, grade B or C)
- plaque index will not exceed 20%
- at least 20 teeth in oral cavity
Key exclusion criteria (6 listed)
- systemic diseases with impact on periodontal health
- medication with impact on periodontal health
- smokers
- pregnant and lactating women
- patients treated with antibiotics in the last 12 months
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 |
|---|---|---|
| SRP+LASER (Dentsply Sirona - SIROLaser Blue)adjunct irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) intrasulcularly to all sites with PD ≥ 4mm | Device | SRP+LASER |
| SRP+HAadjunct hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic intrasulcularly to all sites with PD ≥ 4mm | Device | SRP+HA |
| SRPnon-surgical periodontal therapy (SRP) with utrasonic device and curretes | Device | SRP |
Primary outcome
Probing pocket depth reduction
Time frame: 3 months, 6 months
Change in probing pocket depth after treatment
3 secondary outcomes
Clinical attachment level gain
Time frame: 3 months, 6 months
Bleeding on probing percentage reduction
Time frame: 3 months, 6 months
Residual diseased site number
Time frame: 3 months, 6 months
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 19 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Aleš Fidler, Dr. contact
Aleš Fidler, Dr. study director
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP+LASER (Dentsply Sirona - SIROLaser Blue), SRP+HA and SRP in people with Periodontitis, run by University of Ljubljana at 1 site in Slovenia.
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 5 inclusion and 6 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 19 Sep 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 Slovenia. 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 Eva Skaleric, Dr. (0038640813432, eva.skaleric@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth reduction (time frame: 3 months, 6 months). 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 Sep 2025.