Diode Laser and Green Indocyanine in the Non-surgical Treatment of Periodontitis
NCT ID: NCT04671394
Last Updated: 2020-12-17
Study Results
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2015-10-12
2018-09-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test (FMUD + DLIG)
Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by irrigation with indocyanine green solution and diode laser irradiation.
FMUD + DLIG
Full-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution
Control (FMUD + ST)
Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by sham therapy.
FMUD + ST
Full-Mouth Ultrasonic Debridement + Sham Treatment
Interventions
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FMUD + DLIG
Full-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution
FMUD + ST
Full-Mouth Ultrasonic Debridement + Sham Treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Systemic health
Exclusion Criteria
* Periodontal treatment within the last 12 months or systemic antibiotic intake in the last 3 months
* Pregnancy
18 Years
80 Years
ALL
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Luigi Guida
Full Professor
Principal Investigators
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Luigi Guida, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
References
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Annunziata M, Donnarumma G, Guida A, Nastri L, Persico G, Fusco A, Sanz-Sanchez I, Guida L. Clinical and microbiological efficacy of indocyanine green-based antimicrobial photodynamic therapy as an adjunct to non-surgical treatment of periodontitis: a randomized controlled clinical trial. Clin Oral Investig. 2023 May;27(5):2385-2394. doi: 10.1007/s00784-023-04875-w. Epub 2023 Jan 31.
Other Identifiers
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Laser/01
Identifier Type: -
Identifier Source: org_study_id