Diode Laser and SRP in Chronic Periodontitis (PAPD)
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|ClinicalTrials.gov Identifier: NCT02407379|
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis||Procedure: PAPD+SRP Procedure: Sham-laser +SRP||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||August 28, 2018|
Active Comparator: PAPD+SRP Quadrant
This quadrant, randomly selected in each patients, undergoes treatment with 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 Comparator: Sham-laser + SRP
This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP
Procedure: Sham-laser +SRP
Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing
- PD [ Time Frame: baseline, 1 year ]Change in probing pocket depth
- CAL [ Time Frame: baseline, 1 year ]Change in mean attachment level
- BoP [ Time Frame: baseline, 1 year ]Change in mean bleeding on probing
- PMN, DEC, bacteria [ Time Frame: 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 [ Time Frame: baseline, 1 year ]Individual evaluation of pain/discomfort assessed by a visual analogue score interview
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407379
|Odontostomatologic laser therapy center|
|Florence, Italy, 50143|
|Principal Investigator:||Marco Giannelli||Odontostomatologic laser therapy center|