NCT04671394

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.9 years

First QC Date

December 7, 2020

Last Update Submit

December 15, 2020

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (3)

  • Recession (REC) increase

    6 months

  • Clinical Attachment Level (CAL) gain

    Baseline, 3 and 6 months

  • Microbiological analysis

    6 months

Study Arms (2)

Test (FMUD + DLIG)

EXPERIMENTAL

Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by irrigation with indocyanine green solution and diode laser irradiation.

Procedure: FMUD + DLIG

Control (FMUD + ST)

SHAM COMPARATOR

Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by sham therapy.

Procedure: FMUD + ST

Interventions

FMUD + DLIGPROCEDURE

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

Also known as: Diode laser: Fox ARC, Sweden & Martina, Due Carrare, Italy, indocyanine green photosensitizer solution: Emundo®, Sweden&Martina, Due Carrare, Padova, Italy
Test (FMUD + DLIG)
FMUD + STPROCEDURE

Full-Mouth Ultrasonic Debridement + Sham Treatment

Control (FMUD + ST)

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of moderate to severe periodontitis
  • Systemic health

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36719506DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Luigi Guida, Prof.

    University of Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 17, 2020

Study Start

October 12, 2015

Primary Completion

September 3, 2018

Study Completion

September 3, 2018

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share