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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2026-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

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.

Study Groups

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SRP

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

Group Type EXPERIMENTAL

SRP

Intervention Type DEVICE

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

SRP+LASER

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.

Group Type ACTIVE_COMPARATOR

SRP+LASER (Dentsply Sirona - SIROLaser Blue)

Intervention Type DEVICE

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

SRP+HA

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.

Group Type ACTIVE_COMPARATOR

SRP+HA

Intervention Type DEVICE

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

Interventions

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SRP+LASER (Dentsply Sirona - SIROLaser Blue)

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

Intervention Type DEVICE

SRP+HA

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

Intervention Type DEVICE

SRP

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes