Diode Laser and SRP in Chronic Periodontitis (PAPD)

Odontostomatologic Laser Therapy Center, Florence, Italy

Status: Completed

Conditions: Periodontitis

Treatments: Procedure: PAPD+SRP; Procedure: Sham-laser +SRP

Study type: Interventional

Funder types: Other

Identifiers

NCT02407379

OLTC014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

PAPD+SRP Quadrant

Active Comparator group

Description:

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

Treatment:

Procedure: PAPD+SRP

Sham-laser + SRP

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham-laser +SRP