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

Sponsor

University of Ljubljana (Other)

Overall Status

Recruiting

CT.gov ID

NCT05907161

Collaborator

University Medical Centre Ljubljana (Other)

Enrollment

Location

Arms

23.8

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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 glycosaminoglican 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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Device: SRP+LASER (Dentsply Sirona - SIROLaser Blue) Device: SRP+HA Device: SRP	N/A

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 intrasulcularly.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 9, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SRP The SRP group will receive non-surgical periodontal therapy using an ultrasonic device and curretes in two sessions.	Device: SRP non-surgical periodontal therapy (SRP) with utrasonic device and curretes
Active Comparator: SRP+LASER The SRP+LASER group will receive non-surgical periodontal therapy using an ultrasonic device and curretes in two sessions. After session 2, irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) will be applied intrasulcularly to all sites with PD ≥ 4mm.	Device: SRP+LASER (Dentsply Sirona - SIROLaser Blue) adjunct irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) intrasulcularly to all sites with PD ≥ 4mm
Active Comparator: SRP+HA The SRP+HA group will receive non-surgical periodontal therapy using an ultrasonic device and curretes in two sessions. After session 2, a gel containing hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic acid gel) will be applied intrasulcularly to all sites with PD ≥ 4mm.	Device: SRP+HA adjunct hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic intrasulcularly to all sites with PD ≥ 4mm

Arm

Intervention/Treatment

Experimental: SRP

The SRP group will receive non-surgical periodontal therapy using an ultrasonic device and curretes in two sessions.

Device: SRP

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

Active Comparator: SRP+LASER

The SRP+LASER group will receive non-surgical periodontal therapy using an ultrasonic device and curretes in two sessions. After session 2, irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) will be applied intrasulcularly to all sites with PD ≥ 4mm.

Device: SRP+LASER (Dentsply Sirona - SIROLaser Blue)

adjunct irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) intrasulcularly to all sites with PD ≥ 4mm

Active Comparator: SRP+HA

The SRP+HA group will receive non-surgical periodontal therapy using an ultrasonic device and curretes in two sessions. After session 2, a gel containing hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic acid gel) will be applied intrasulcularly to all sites with PD ≥ 4mm.

Device: SRP+HA

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

Outcome Measures

Primary Outcome Measures

Probing pocket depth reduction [3 months, 6 months]
Change in probing pocket depth

Secondary Outcome Measures

Clinical attachement level [3 months, 6 months]
Change in clinical attachement level
Bleeding on probing [3 months, 6 months]
Bleeding after measurment of pocket depth
Residual diseased site number [3 months, 6 months]
No of sites with PD ≥ 4mm and bleeding on probing

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univerity Medical Center Ljubljana	Ljubljana		Slovenia	1000

Sponsors and Collaborators

University of Ljubljana
University Medical Centre Ljubljana

Investigators

Study Director: Aleš Fidler, Dr., University Medical Centre Ljubljana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Ljubljana

ClinicalTrials.gov Identifier:

NCT05907161

Other Study ID Numbers:

HA AND LASERS IN PERIO TH

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Study Results

No Results Posted as of Jun 18, 2023