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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907161
• Other study ID #: HA AND LASERS IN PERIO TH
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: University of Ljubljana
• Contact: Eva Skaleric, Dr.
• Phone: 0038640813432
• Email: eva.skaleric[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Device:
• SRP+LASER (Dentsply Sirona - SIROLaser Blue)
adjunct irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) intrasulcularly to all sites with PD = 4mm
• SRP+HA
adjunct hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic intrasulcularly to all sites with PD = 4mm
• SRP
non-surgical periodontal therapy (SRP) with utrasonic device and curretes

Locations

Country	Name	City	State
Slovenia	Univerity Medical Center Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University of Ljubljana	University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket depth reduction	Change in probing pocket depth after treatment	3 months, 6 months
Secondary	Clinical attachment level gain	Change in clinical attachment level after treatment	3 months, 6 months
Secondary	Bleeding on probing percentage reduction	Bleeding after measurement of pocket depth, reduction after treatment	3 months, 6 months
Secondary	Residual diseased site number	No of sites with PD = 4mm and bleeding on probing after treatment	3 months, 6 months