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NCT Number: NCT05907161

Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univerity Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Eva Skaleric, Dr.

CONTACT

[email protected]

0038615222769

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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+HA

Device

adjunct hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic intrasulcularly to all sites with PD ≥ 4mm

SRP

Device

non-surgical periodontal therapy (SRP) with utrasonic device and curretes

Primary outcomes

  1. Probing pocket depth reduction

    Time frame: 3 months, 6 months

    Change in probing pocket depth after treatment

Secondary outcomes

  1. Clinical attachment level gain

    Time frame: 3 months, 6 months

    Change in clinical attachment level after treatment

  2. Bleeding on probing percentage reduction

    Time frame: 3 months, 6 months

    Bleeding after measurement of pocket depth, reduction after treatment

  3. Residual diseased site number

    Time frame: 3 months, 6 months

    No of sites with PD ≥ 4mm and bleeding on probing after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Aleš Fidler, Dr.

CONTACT

[email protected]

Eva Skaleric, Dr.

CONTACT

[email protected]

0038640813432

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Collaborators

  • University Medical Centre Ljubljana

Registry information

Official study title

The Effect of Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy in Patients With Periodontitis

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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