Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy
The Effect of Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy in Patients With Periodontitis
1 other identifier
interventional
45
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2023
CompletedStudy Start
First participant enrolled
June 9, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedSeptember 19, 2025
September 1, 2025
2.7 years
June 7, 2023
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Probing pocket depth reduction
Change in probing pocket depth after treatment
3 months, 6 months
Secondary Outcomes (3)
Clinical attachment level gain
3 months, 6 months
Bleeding on probing percentage reduction
3 months, 6 months
Residual diseased site number
3 months, 6 months
Study Arms (3)
SRP
EXPERIMENTALThe SRP group will receive non-surgical periodontal therapy using an ultrasonic device and curettes in two sessions.
SRP+LASER
ACTIVE COMPARATORThe 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 COMPARATORThe 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.
Interventions
adjunct irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) intrasulcularly to all sites with PD ≥ 4mm
adjunct hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic intrasulcularly to all sites with PD ≥ 4mm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Ljubljanalead
- University Medical Centre Ljubljanacollaborator
Study Sites (1)
Univerity Medical Center Ljubljana
Ljubljana, 1000, Slovenia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aleš Fidler, Dr.
University Medical Centre Ljubljana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Masking Details
- Before initial treatment the care provider will randomly pick an envelope with one of the three treatment modalities. At follow-up visits the investigator will perform the periodontal examination without having access to the patients data.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2023
First Posted
June 18, 2023
Study Start
June 9, 2023
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share