Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV

NCT06426550 | Completed

• 1 other identifier: 78007624.4.0000.5626
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to evaluate photodynamic therapy and photobiomodulation in the periodontitis treatment. To evaluate the clinical and microbiological response of conventional periodontal treatment associated with photodynamic therapy and photobiomodulation with red or infrared laser. Participants will receive periodontal treatment carried out with the use 0.005% methylene blue and laser therapy (photodynamic therapy), associated with conventional periodontal treatment, as well as the use of photobiomodulation with red or infrared laser associated with conventional periodontal treatment in participants with periodontitis. So, twenty periodontitis patients will be selected and separated in two groups compared with placebo. Clinical and microbiological parameters will be evaluated at baseline and 3 months after periodontal treatment: plaque Index, bleeding on probe, probing depth, gingival recession and clinical attachment level.

Conditions

Periodontitis; Periodontitis, Adult

Keywords

Periodontal Diseases; Periodontal Pocket; Laser Therapy; Methylene Blue

Outcome Measures

Primary Outcomes (5)

• Plaque index (PI)

  Plaque index will be expressed in percentage per individual to evaluate the supragingival plaque control.

  Baseline and 3 months

• Bleeding on probing (BOP)

  Bleeding on probing (BOP) will be expressed in percentage per individual to evaluate presence of BOP \<20% good results.

  Baseline and 3 months

• Pocket probing depth (PPD)

  Pocket probing depth (PPD) will be evaluated in millimeters. The measure will be performed at six sites per tooth using a periodontal probe. The PPD corresponds to the distance from the gingival margin to the apical portion of the gingival sulcus or periodontal pocket.

  Baseline and 3 months

• Gingival recession (GR)

  Gingival recession (GR) will be measured clinically in millimeters with a periodontal probe as the distance from the cemento-enamel junction to the depth of the free gingival margin.

  Baseline and 3 months

• Clinical attachment level (CAL)

  Clinical attachment level (CAL) will be measured clinically in millimeters with a periodontal probe and corresponds as the distance from the cemento-enamel junction to the base of the periodontal pocket. CAL represents the extension of periodontal support that has been lost around a tooth.

  Baseline and 3 months

Secondary Outcomes (1)

• Microbiogical analysis

  Baseline and 3 months

Study Arms (4)

Antimicrobial photodynamic therapy and 0.005% methylene blue (aPDT)

EXPERIMENTAL

Photosensitization will be performed with 0.005% methylene blue gel for 5 minutes, and photodynamic therapy will be applied with a red laser (660 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW.

Procedure: Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT)

Photobiomodulation with a red laser (PBM-RL)

EXPERIMENTAL

Photobiomodulation will be performed with a red laser (660 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. The application of the gel with an empty syringe will be simulated, and waited 5 minutes.

Procedure: Photobiomodulation with a red laser (PBM-RL)

Photobiomodulation with an infrared laser (PBM-IRL)

EXPERIMENTAL

Photobiomodulation will be performed with an infrared laser (808 nm) using a DuoⓇ laser with the optical fiber inside the periodontal pocket in back and forth movements, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. The application of the gel with an empty syringe will be simulated, and waited 5 minutes.

Procedure: Photobiomodulation with an infrared laser (PBM-IRL)

Saline solution - Control (C)

PLACEBO COMPARATOR

Saline gel will be applied in the periodontal pocket and, after 5 minutes, the laser application will be simulated, with the device in inactive mode.

Procedure: Saline solution

Interventions

Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT) PROCEDURE

Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by antimicrobial photodynamic therapy (aPDT) with 0.005% methylene blue as the photosensitizer.

Antimicrobial photodynamic therapy and 0.005% methylene blue (aPDT)

Photobiomodulation with a red laser (PBM-RL) PROCEDURE

Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by Photobiomodulation with a red laser (PBM-RL).

Photobiomodulation with a red laser (PBM-RL)

Saline solution PROCEDURE

Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by application of saline solution as the control treatment.

Saline solution - Control (C)

Photobiomodulation with an infrared laser (PBM-IRL) PROCEDURE

Conventional periodontal treatment, consisting of scaling and root planing, will be performed using ultrasonic instrumentation complemented by Gracey curettes, followed by photobiomodulation with an infrared laser (PBM-IRL).

Photobiomodulation with an infrared laser (PBM-IRL)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants with periodontal disease;
• Four or more periodontal sites with PPD≥6 mm and CAL≥5 mm, non-adjacent;
• Generalized periodontitis, with more than 30% of the sites involved (Caton et al., 2018);
• Stages III and IV of periodontal disease (Caton et al., 2018);

You may not qualify if:

• Participants with hypersensitivity to the components of the 0.005% methylene blue gel;
• Received periodontal treatment in the last six months;
• Drugs (alcoholics, use of anti-inflammatories and antibiotics in the last 3 months);
• Any evidence of systemic modifying factors which may directly interfere with the completion of the work (bias), such as:
• Pregnant and breastfeeding women;
• Hormone replacement therapy;
• Smoking;
• Hyperglycemia;
• Osteoporosis;
• Diagnosed with HIV+ or AIDS.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Fluminense Federal University

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

Location

Related Publications (3)

• Akram Z, Al-Shareef SA, Daood U, Asiri FY, Shah AH, AlQahtani MA, Vohra F, Javed F. Bactericidal Efficacy of Photodynamic Therapy Against Periodontal Pathogens in Periodontal Disease: A Systematic Review. Photomed Laser Surg. 2016 Apr;34(4):137-49. doi: 10.1089/pho.2015.4076. Epub 2016 Mar 16.

  PMID: 26982216 BACKGROUND

• Akram Z. How effective is adjunctive antimicrobial photodynamic therapy in treating deep periodontal pockets in periodontal disease? A systematic review. J Investig Clin Dent. 2018 Nov;9(4):e12345. doi: 10.1111/jicd.12345. Epub 2018 Jun 4.

  PMID: 29863310 BACKGROUND

• Ren C, McGrath C, Jin L, Zhang C, Yang Y. The effectiveness of low-level laser therapy as an adjunct to non-surgical periodontal treatment: a meta-analysis. J Periodontal Res. 2017 Feb;52(1):8-20. doi: 10.1111/jre.12361. Epub 2016 Mar 2.

  PMID: 26932392 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Chronic Periodontitis; Periodontal Diseases; Periodontal Pocket

Interventions

Methylene Blue; Low-Level Light Therapy; Saline Solution

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Laser Therapy; Therapeutics; Phototherapy; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gabriela AC Camargo, Doctor

  Fluminense Federal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be carried out by a blind clinician for the initial assessment of participants, using a computer program (Spyder 5.5.4), in which each patient will be randomly selected to define the site to receive one of the treatments. Next, gels will be encoded in a syringe and applied by a researcher blind to the sites and reagents, each of the 4 sites will receive one of the following treatments: 1 - photosensitization with 0.005% AM gel (Fórmula e Ação Farmácia, São Paulo, SP, Brazil) for 5 minutes, and apply photodynamic therapy with a red laser; 2 - photobiomodulation with red laser; 3 - photobiomodulation with infrared laser; and 4 - control, application of saline gel and, after 5 minutes, simulate the application of the laser, with the device in inactive mode, in order to maintain blinding of the patients (control). In groups 2 and 3, as no gel will be applied, the application of the gel with an empty syringe will be simulated, to keep patients blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Clinical, laboratory, longitudinal split-mouth study carried out in humans.

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: May 6, 2024
• Primary Completion: January 26, 2026
• Study Completion: February 2, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)