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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAPD+SRP Quadrant | Active Comparator | This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP |
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| Sham-laser + SRP | Sham Comparator | This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAPD+SRP | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| PD | Change in probing pocket depth | baseline, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| CAL | Change in mean attachment level | baseline, 1 year |
| BoP | Change in mean bleeding on probing | baseline, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Giannelli | Odontostomatologic laser therapy center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odontostomatologic laser therapy center | Florence | 50143 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29349511 | Result | 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 investigating its efficacy and patient-reported outcomes at 1 year. Lasers Med Sci. 2018 Jul;33(5):991-1002. doi: 10.1007/s10103-018-2441-9. Epub 2018 Jan 18. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Sham-laser +SRP | Procedure | Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing |
|
| 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 |
| Patient-reported outcomes | Individual evaluation of pain/discomfort assessed by a visual analogue score interview | baseline, 1 year |