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Diode Laser and SRP in Chronic Periodontitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02407379
Acronym
PAPD
Enrollment
24
Registered
2015-04-03
Start date
2015-10-31
Completion date
2018-08-28
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

Laser, periodontitis, scaling root planing, bacteria, PMN

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.

Interventions

PROCEDUREPAPD+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).

PROCEDURESham-laser +SRP

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

Sponsors

Odontostomatologic Laser Therapy Center, Florence, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
PDbaseline, 1 yearChange in probing pocket depth

Secondary

MeasureTime frameDescription
CALbaseline, 1 yearChange in mean attachment level
BoPbaseline, 1 yearChange in mean bleeding on probing
PMN, DEC, bacteriabaseline, 1 yearChange 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 outcomesbaseline, 1 yearIndividual evaluation of pain/discomfort assessed by a visual analogue score interview

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026