Diode Laser and SRP in Chronic Periodontitis

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Procedure: Sham-laser +SRP; Procedure: PAPD+SRP

• Registration Number: NCT02407379
• Lead Sponsor: Odontostomatologic Laser Therapy Center, Florence, Italy

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.

Study Timeline

• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Study Start: 2015-10
• Primary Completion: 2016-10
• Status Verified: 2018-08
• Study Completion: 2018-08-28
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sham-laser + SRP	Sham-laser +SRP	This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP
PAPD+SRP Quadrant	PAPD+SRP	This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP

Primary Outcome Measures

Name	Time	Method
PD	baseline, 1 year	Change in probing pocket depth

Secondary Outcome Measures

Name	Time	Method
CAL	baseline, 1 year	Change in mean attachment level
BoP	baseline, 1 year	Change in mean bleeding on probing
PMN, DEC, bacteria	baseline, 1 year	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.
Patient-reported outcomes	baseline, 1 year	Individual evaluation of pain/discomfort assessed by a visual analogue score interview

Trial Locations

Locations (1)

Odontostomatologic laser therapy center; 🇮🇹 Florence, Italy