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Completed

NCT Number: NCT04671394

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMUD + DLIG

Procedure

Full-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution

Other names: Diode laser: Fox ARC, Sweden & Martina, Due Carrare, Italy, indocyanine green photosensitizer solution: Emundo®, Sweden&Martina, Due Carrare, Padova, Italy

FMUD + ST

Procedure

Full-Mouth Ultrasonic Debridement + Sham Treatment

Primary outcomes

  1. Probing depth (PD) reduction

    Time frame: 6 months

    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 outcomes

  1. Recession (REC) increase

    Time frame: 6 months

    The distance between the gingival margin and the cemento-enamel junction or the margin of the restoration.

  2. Clinical Attachment Level (CAL) gain

    Time frame: Baseline, 3 and 6 months

    Calculated as PD plus REC.

  3. Microbiological analysis

    Time frame: 6 months

    Semi-quantitative analysis by PCR

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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