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Diode Laser and Green Indocyanine in the Non-surgical Treatment of Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FMUD + DLIG
FMUD + ST
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Diagnosis of moderate to severe periodontitis
  • Systemic health

Exclusion criteria:

  • Systemic diseases requiring antibiotic prophylaxis or other systemic medication that could affect the patient's clinical response
  • Periodontal treatment within the last 12 months or systemic antibiotic intake in the last 3 months
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Test (FMUD + DLIG)

    Control (FMUD + ST)

    Arm Description

    Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by irrigation with indocyanine green solution and diode laser irradiation.

    Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by sham therapy.

    Outcomes

    Primary Outcome Measures

    Probing depth (PD) reduction
    The distance between the bottom of the pocket and the gingival margin recorded with a manual probe using a light force and measured to the closest millimeter

    Secondary Outcome Measures

    Recession (REC) increase
    The distance between the gingival margin and the cemento-enamel junction or the margin of the restoration.
    Clinical Attachment Level (CAL) gain
    Calculated as PD plus REC.
    Microbiological analysis
    Semi-quantitative analysis by PCR

    Full Information

    First Posted
    December 7, 2020
    Last Updated
    December 15, 2020
    Sponsor
    University of Campania "Luigi Vanvitelli"
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04671394
    Brief Title
    Diode Laser and Green Indocyanine in the Non-surgical Treatment of Periodontitis
    Official Title
    The Use of Diode Laser and Green Indocyanine Solution in Adjunct to Full-mouth Ultrasonic Debridement in the Treatment of Periodontitis: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 12, 2015 (Actual)
    Primary Completion Date
    September 3, 2018 (Actual)
    Study Completion Date
    September 3, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campania "Luigi Vanvitelli"

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a parallel-group, randomized controlled clinical trial aimed to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and green indocyanine in the full-mouth ultrasonic debridement of patients affected by periodontitis.
    Detailed Description
    Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth and is primarily caused by the subgingival inflammation induced by the bacterial oral biofilm. Several risk factors may condition its development and progression and, if untreated, periodontitis may lead to tooth loss and severe functional and aesthetic impairments. A central role in the non-surgical treatment of periodontitis is played by the manual and ultrasonic debridement of supra and subgingival bacterial deposits. The benefit of a fully ultrasonic approach lies in the knowledge that removing radicular structure is not a prerequisite for periodontal healing. However, non-surgical therapy has limitations due to limited access to some sites (furcation areas, concavities, grooves, distal sites of molars, and deep pockets), which may impair periodontal healing due to the persistence of pathogens and subsequent recolonization. In this context, the use of diode laser in combination with photoactivated solutions has been proposed as an adjunct treatment to conventional periodontal therapy to enhance the antibacterial effect and improve clinical effects, especially in areas of difficult access. In view of theme relevance and the existence of conflicting results in the literature, the aim of the present parallel-group, randomized controlled clinical trial is to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and indocyanine green (DLIG) in the full-mouth ultrasonic debridement (FMUD) of patients affected by periodontitis. 24 patients will be treated by FMUD and, after 7 days, randomly allocated half to the test and a half to the control group. In the test group, patients will receive an adjunctive treatment in periodontal sites with an initial pocket depth > 4mm consisting of the use of a diode laser device (Fox ARC, Sweden & Martina, Due Carrare, Italy) after pocket irrigation by a solution of indocyanine green (Emundo®, Sweden&Martina, Due Carrare, Padova, Italy), whereas the patients in the control group will receive sham treatment (ST). The same treatment will be repeated three weeks after in both the test and control groups. Clinical assessment and microbiological analysis of subgingival plaque will be performed at baseline and after 3 and 6 months.

    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
    ParticipantOutcomes Assessor
    Masking Description
    The patients in the control group are treated by the same operator and received a sham laser treatment in which, after pocket irrigation with the photosensitizer solution, the laser tip is inserted in the pockets but the laser unit is kept off.
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test (FMUD + DLIG)
    Arm Type
    Experimental
    Arm Description
    Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by irrigation with indocyanine green solution and diode laser irradiation.
    Arm Title
    Control (FMUD + ST)
    Arm Type
    Sham Comparator
    Arm Description
    Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by sham therapy.
    Intervention Type
    Procedure
    Intervention Name(s)
    FMUD + DLIG
    Other Intervention Name(s)
    Diode laser: Fox ARC, Sweden & Martina, Due Carrare, Italy, indocyanine green photosensitizer solution: Emundo®, Sweden&Martina, Due Carrare, Padova, Italy
    Intervention Description
    Full-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution
    Intervention Type
    Procedure
    Intervention Name(s)
    FMUD + ST
    Intervention Description
    Full-Mouth Ultrasonic Debridement + Sham Treatment
    Primary Outcome Measure Information:
    Title
    Probing depth (PD) reduction
    Description
    The distance between the bottom of the pocket and the gingival margin recorded with a manual probe using a light force and measured to the closest millimeter
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Recession (REC) increase
    Description
    The distance between the gingival margin and the cemento-enamel junction or the margin of the restoration.
    Time Frame
    6 months
    Title
    Clinical Attachment Level (CAL) gain
    Description
    Calculated as PD plus REC.
    Time Frame
    Baseline, 3 and 6 months
    Title
    Microbiological analysis
    Description
    Semi-quantitative analysis by PCR
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Diagnosis of moderate to severe periodontitis Systemic health Exclusion criteria: Systemic diseases requiring antibiotic prophylaxis or other systemic medication that could affect the patient's clinical response Periodontal treatment within the last 12 months or systemic antibiotic intake in the last 3 months Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luigi Guida, Prof.
    Organizational Affiliation
    University of Campania "Luigi Vanvitelli"
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Diode Laser and Green Indocyanine in the Non-surgical Treatment of Periodontitis

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