NCT02407379

Brief Summary

The purpose of this study is to compare the efficacy of photoablative and photodynamic diode laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of periodontitis.

Trial Health

87
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

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 9, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

July 9, 2014

Last Update Submit

August 28, 2018

Conditions

Periodontitis

Keywords

Laserperiodontitisscaling root planingbacteriaPMN

Outcome Measures

Primary Outcomes (1)

  • PD

    Change in probing pocket depth

    baseline, 1 year

Secondary Outcomes (4)

  • CAL

    baseline, 1 year

  • BoP

    baseline, 1 year

  • PMN, DEC, bacteria

    baseline, 1 year

  • Patient-reported outcomes

    baseline, 1 year

Study Arms (2)

PAPD+SRP Quadrant

ACTIVE COMPARATOR

This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP

Procedure: PAPD+SRP

Sham-laser + SRP

SHAM COMPARATOR

This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP

Procedure: Sham-laser +SRP

Interventions

PAPD+SRPPROCEDURE

Photoablation of the gingival epithelium was performed with at 810 nm diode laser (1 W output power, continuous wave mode, 66.7 J/cm2, a 0.6 mm optical fiber). SRP was performed using curettes. The periodontal tissues and the dental root were rinsed with the photosensitizer agent methylene blue (0.3% w/v in water). After 5 min., the treated areas were irradiated with at 635 nm diode laser (100 mW output power, continuous wave mode, 0.6 mm optic fiber). The photodynamic treatment was repeated once weekly until normalization of the cytodiagnostic parameters (range: 4-10 applications).

PAPD+SRP Quadrant
Sham-laser +SRPPROCEDURE

Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing

Sham-laser + SRP

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Periodontitis:Presence of at least two teeth with at least one site with pocket probing depth (PD) ranging from 4 to 10 mm in each upper maxillary quadrant and with bleeding on probing (BOP)
  • A minimum of five natural teeth in each studied quadrant.

You may not qualify if:

  • History of systemic diseases (diabetes mellitus, cancer, HIV, metabolic and endocrine diseases)
  • Pregnancy or lactation
  • Chronic high-dose steroid use
  • Previous or current radiation or immunosuppressive therapies
  • Ongoing orthodontic treatments
  • Extensive carious lesions
  • Recurrent antibiotic medications during the 6 months preceding the study
  • Class III tooth mobility
  • Heavy contamination by spirochetes and fungal pathogens on tongue and oral mucosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odontostomatologic laser therapy center

Florence, 50143, Italy

Location

Related Publications (1)

  • Giannelli M, Materassi F, Fossi T, Lorenzini L, Bani D. Treatment of severe periodontitis with a laser and light-emitting diode (LED) procedure adjunctive to scaling and root planing: a double-blind, randomized, single-center, split-mouth clinical trial investigating its efficacy and patient-reported outcomes at 1 year. Lasers Med Sci. 2018 Jul;33(5):991-1002. doi: 10.1007/s10103-018-2441-9. Epub 2018 Jan 18.

    PMID: 29349511RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Marco Giannelli

    Odontostomatologic laser therapy center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2014

First Posted

April 3, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

August 28, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)