Skip to main content
OpenTrials
Completed

NCT Number: NCT02407379

Diode Laser and SRP in Chronic Periodontitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odontostomatologic laser therapy center

Florence, 50143, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • A minimum of five natural teeth in each studied quadrant.

Exclusion criteria

  • History of systemic diseases (diabetes mellitus, cancer, HIV, metabolic and endocrine diseases)
  • Pregnancy or lactation
  • Chronic high-dose steroid use
  • Previous or current radiation or immunosuppressive therapies
  • Ongoing orthodontic treatments
  • Extensive carious lesions
  • Recurrent antibiotic medications during the 6 months preceding the study
  • Class III tooth mobility
  • Heavy contamination by spirochetes and fungal pathogens on tongue and oral mucosa

Treatment and study plan

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).

Sham-laser +SRP

Procedure

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

Primary outcomes

  1. PD

    Time frame: baseline, 1 year

    Change in probing pocket depth

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Odontostomatologic Laser Therapy Center, Florence, Italy

Other

Registry information

Official study title

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

Acronym: PAPD

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Apr 3, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.