Diode Laser and SRP in Chronic Periodontitis

Periodontitis Clinical Trial

— PAPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407379
• Other study ID #: OLTC014
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: August 28, 2018

Study information

• Verified date: August 2018
• Source: Odontostomatologic Laser Therapy Center, Florence, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 28, 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Italy	Odontostomatologic laser therapy center	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Odontostomatologic Laser Therapy Center, Florence, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD	Change in probing pocket depth	baseline, 1 year
Secondary	CAL	Change in mean attachment level	baseline, 1 year
Secondary	BoP	Change in mean bleeding on probing	baseline, 1 year
Secondary	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
Secondary	Patient-reported outcomes	Individual evaluation of pain/discomfort assessed by a visual analogue score interview	baseline, 1 year