Diode Laser and SRP in Chronic Periodontitis (PAPD)

Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: PAPD+SRP; Procedure: Sham-laser +SRP

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50143
    • Odontostomatologic Laser Therapy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PAPD+SRP Quadrant; This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP	Procedure: PAPD+SRP; 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).
Sham Comparator: Sham-laser + SRP; This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP	Procedure: Sham-laser +SRP; Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD	Change in probing pocket depth	baseline, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAL	Change in mean attachment level	baseline, 1 year
BoP	Change in mean bleeding on probing	baseline, 1 year
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.	baseline, 1 year
Patient-reported outcomes	Individual evaluation of pain/discomfort assessed by a visual analogue score interview	baseline, 1 year

Collaborators and Investigators

• Sponsor: Odontostomatologic Laser Therapy Center, Florence, Italy
• Investigators: Principal Investigator: Marco Giannelli, Odontostomatologic Laser Therapy Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: periodontitis; bacteria; Laser; scaling root planing; PMN
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: OLTC014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No