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

About this trial
This is an interventional treatment trial for Periodontitis
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
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
NCT ID
NCT04671394
First Posted
December 7, 2020
Last Updated
December 15, 2020
Sponsor
University of Campania "Luigi Vanvitelli"
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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