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Diode Laser and SRP in Chronic Periodontitis (PAPD)

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PAPD+SRP
Sham-laser +SRP
Sponsored by
Odontostomatologic Laser Therapy Center, Florence, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Laser, periodontitis, scaling root planing, bacteria, PMN

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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)
  2. A minimum of five natural teeth in each studied quadrant.

Exclusion Criteria:

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

Sites / Locations

  • Odontostomatologic laser therapy center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

PAPD+SRP Quadrant

Sham-laser + SRP

Arm Description

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

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

Outcomes

Primary Outcome Measures

PD
Change in probing pocket depth

Secondary Outcome Measures

CAL
Change in mean attachment level
BoP
Change in mean bleeding on probing
PMN, DEC, bacteria
Change in mean additional disease markers, namely polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples.
Patient-reported outcomes
Individual evaluation of pain/discomfort assessed by a visual analogue score interview

Full Information

First Posted
July 9, 2014
Last Updated
August 28, 2018
Sponsor
Odontostomatologic Laser Therapy Center, Florence, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT02407379
Brief Title
Diode Laser and SRP in Chronic Periodontitis
Acronym
PAPD
Official Title
Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Odontostomatologic Laser Therapy Center, Florence, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The present study is a randomized, blinded, controlled clinical trial, which used a split-mouth design. All patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed. Twenty-four patients were studied. Maxillary left or right quadrants were randomly assigned to PAPD laser treatment or sham-treatment and SRP. PAPD consisted of: i) photoablative gingival epithelium with diode laser (λ 810 nm, 1 W); ii) photodynamic treatments (4-10 weekly) with diode laser (λ 635 nm, 100 mW) and 0.3% methylene blue as photoactive antiseptic, performed after SRP. Sham-treatment was similar but with switched off laser. Efficacy evaluations, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) was performed at baseline ,1year, and year 3 using a conventional manual periodontal probe. Polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples at baseline, 6 month and 1, 3, 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Laser, periodontitis, scaling root planing, bacteria, PMN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAPD+SRP Quadrant
Arm Type
Active Comparator
Arm Description
This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP
Arm Title
Sham-laser + SRP
Arm Type
Sham Comparator
Arm Description
This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP
Intervention Type
Procedure
Intervention Name(s)
PAPD+SRP
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Sham-laser +SRP
Intervention Description
Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing
Primary Outcome Measure Information:
Title
PD
Description
Change in probing pocket depth
Time Frame
baseline, 1 year
Secondary Outcome Measure Information:
Title
CAL
Description
Change in mean attachment level
Time Frame
baseline, 1 year
Title
BoP
Description
Change in mean bleeding on probing
Time Frame
baseline, 1 year
Title
PMN, DEC, bacteria
Description
Change in mean additional disease markers, namely polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples.
Time Frame
baseline, 1 year
Title
Patient-reported outcomes
Description
Individual evaluation of pain/discomfort assessed by a visual analogue score interview
Time Frame
baseline, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Giannelli
Organizational Affiliation
Odontostomatologic laser therapy center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odontostomatologic laser therapy center
City
Florence
ZIP/Postal Code
50143
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29349511
Citation
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.
Results Reference
result

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Diode Laser and SRP in Chronic Periodontitis

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