Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04671394 |
| Other study ID # |
Laser/01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 12, 2015 |
| Est. completion date |
September 3, 2018 |
Study information
| Verified date |
December 2020 |
| Source |
University of Campania "Luigi Vanvitelli" |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
