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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: PAPD+SRP Procedure: Sham-laser +SRP Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: PAPD+SRP Quadrant
This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP
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 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




Primary Outcome Measures :
  1. PD [ Time Frame: baseline, 1 year ]
    Change in probing pocket depth


Secondary Outcome Measures :
  1. CAL [ Time Frame: baseline, 1 year ]
    Change in mean attachment level

  2. BoP [ Time Frame: baseline, 1 year ]
    Change in mean bleeding on probing

  3. 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.

  4. Patient-reported outcomes [ Time Frame: baseline, 1 year ]
    Individual evaluation of pain/discomfort assessed by a visual analogue score interview



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Italy
Odontostomatologic laser therapy center
Florence, Italy, 50143
Sponsors and Collaborators
Odontostomatologic Laser Therapy Center, Florence, Italy
Investigators
Principal Investigator: Marco Giannelli Odontostomatologic laser therapy center

Publications of Results:
Responsible Party: Odontostomatologic Laser Therapy Center, Florence, Italy
ClinicalTrials.gov Identifier: NCT02407379     History of Changes
Other Study ID Numbers: OLTC014
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Odontostomatologic Laser Therapy Center, Florence, Italy:
Laser
periodontitis
scaling root planing
bacteria
PMN

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases