search
Back to results

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

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
SRP+LASER (Dentsply Sirona - SIROLaser Blue)
SRP+HA
SRP
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Univerity Medical Center LjubljanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

SRP

SRP+LASER

SRP+HA

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Probing pocket depth reduction
Change in probing pocket depth after treatment

Secondary Outcome Measures

Clinical attachment level gain
Change in clinical attachment level after treatment
Bleeding on probing percentage reduction
Bleeding after measurement of pocket depth, reduction after treatment
Residual diseased site number
No of sites with PD ≥ 4mm and bleeding on probing after treatment

Full Information

First Posted
June 7, 2023
Last Updated
October 4, 2023
Sponsor
University of Ljubljana
Collaborators
University Medical Centre Ljubljana
search

1. Study Identification

Unique Protocol Identification Number
NCT05907161
Brief Title
Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy
Official Title
The Effect of Low Laser Therapy and Hyaluronic Acid as an Adjunct to Non-surgical Periodontal Therapy in Patients With Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ljubljana
Collaborators
University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
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.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SRP
Arm Type
Experimental
Arm Description
The SRP group will receive non-surgical periodontal therapy using an ultrasonic device and curettes in two sessions.
Arm Title
SRP+LASER
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SRP+HA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SRP+LASER (Dentsply Sirona - SIROLaser Blue)
Intervention Description
adjunct irradiation with a diode laser (Dentsply Sirona - SIROLaser Blue) intrasulcularly to all sites with PD ≥ 4mm
Intervention Type
Device
Intervention Name(s)
SRP+HA
Intervention Description
adjunct hyaluronic acid (Regedent, HyaDENT Cross linked hyaluronic intrasulcularly to all sites with PD ≥ 4mm
Intervention Type
Device
Intervention Name(s)
SRP
Intervention Description
non-surgical periodontal therapy (SRP) with utrasonic device and curretes
Primary Outcome Measure Information:
Title
Probing pocket depth reduction
Description
Change in probing pocket depth after treatment
Time Frame
3 months, 6 months
Secondary Outcome Measure Information:
Title
Clinical attachment level gain
Description
Change in clinical attachment level after treatment
Time Frame
3 months, 6 months
Title
Bleeding on probing percentage reduction
Description
Bleeding after measurement of pocket depth, reduction after treatment
Time Frame
3 months, 6 months
Title
Residual diseased site number
Description
No of sites with PD ≥ 4mm and bleeding on probing after treatment
Time Frame
3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Skaleric, Dr.
Phone
0038640813432
Email
eva.skaleric@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aleš Fidler, Dr.
Email
ales.fidler@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleš Fidler, Dr.
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Study Director
Facility Information:
Facility Name
Univerity Medical Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Skaleric, Dr.
Phone
0038615222769
Email
eva.skaleric@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs