Diode Laser and Green Indocyanine in the Non-surgical Treatment of Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

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.
    

Intervention name(s): FMUD + DLIG; FMUD + ST
Intervention type(s): Procedure; Procedure
Intervention description(s): Full-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution; Full-Mouth Ultrasonic Debridement + Sham Treatment
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 MeSH terms: Photosensitizing Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment