Overview

This trial is active, not recruiting.

Condition periodontitis
Treatments photoablative - photodynamic 4x4 dental laser system p/n 88832224, scaling - root planing
Phase phase 4
Sponsor Odontostomatologic Laser Therapy Center, Florence, Italy
Start date October 2015
End date October 2016
Trial size 27 participants
Trial identifier NCT02407379, OLTC014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Treatment with PAPD+ SRP
photoablative - photodynamic 4x4 dental laser system p/n 88832224 4x4 dental Laser System p/n 88832224
Photoablative 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-treatment was similar but with switched off laser
scaling - root planing
(No Intervention)
Quadrant treated with sham-laser + SRP

Primary Outcomes

Measure
Change in probing pocket depth
time frame: baseline, 1 and 3 years

Secondary Outcomes

Measure
Change in mean attachment level
time frame: baseline, 1and 3 years
Change in mean bleeding on probing
time frame: baseline,1and 3 years
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,1and 3 years

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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

Additional Information

Official title Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis
Principal investigator Marco Giannelli
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Odontostomatologic Laser Therapy Center, Florence, Italy.