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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Periodontitis, Adult
• Intervention / Treatment: Procedure: Antimicrobial photodynamic therapy and 0.005% methylene blue (PDT); Procedure: Photobiomodulation with a red laser (PBM-RL); Procedure: Photobiomodulation with an infrared laser (PBM-IRL); Procedure: Saline solution

Detailed Description

Periodontitis is a chronic, inflammatory and multifactorial disease, caused by an interaction between debiotic biofilm and its products and an exacerbated host response, leading to the progressive destruction of the supporting periodontium (bone, cement and periodontal ligament), causing loss of clinical attachment. and radiographic, bleeding on probing and periodontal pocket formation. Periodontal disease has a high prevalence and is one of the main causes of edentulism, with a great negative impact on chewing function, aesthetics and quality of life related to oral health. It is, therefore, considered a serious public health problem.

Conventional periodontal therapy consists of scaling and root planing (SRP) and control of supragingival plaque, but in some cases it has been shown to be ineffective in treating periodontitis, especially in difficult to access areas such as furcations and deep pockets. These cases benefit from adjuvant therapies, such as laser therapy, to help heal periodontal tissues, reduce microorganisms and improve clinical parameters.

Photobiomodulation and photodynamic therapy have been widely applied in the treatment of periodontal disease, due to their clinical, cellular and bactericidal effects. When associated with conventional periodontal therapy, its benefits increase, promoting a significant reduction in probing depth, number of deep pockets and bleeding. Furthermore, significant reduction of periodontopathogens and Candida albicans can be observed in the literature after photobiomodulation and photodynamic therapy.

Despite the benefits found when different laser therapy protocols are used in periodontal treatment, due to the lack of studies with high methodological quality and weak evidence in the existing literature, more studies are needed to prove their effects, establish appropriate protocols and evaluate the antimicrobial potential in periodontopathogens, which remains debatable, as recent systematic reviews point out.

The direct benefits of this study are the treatment of periodontal disease for the participants and for the scientific community to indicate new forms of periodontal therapy using different protocols of laser therapy associated with periodontal instrumentation. All tooth pocket sites in all groups will receive treatment.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro
    • Nova Friburgo, Rio de Janeiro, Brazil, 28625650
      • Fluminense Federal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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);

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline solution - Control (C); 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; 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.
Experimental: Antimicrobial photodynamic therapy and 0.005% methylene blue (aPDT); 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); 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.
Experimental: Photobiomodulation with a red laser (PBM-RL); 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); 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).
Experimental: Photobiomodulation with an infrared laser (PBM-IRL); 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); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiogical analysis	Pooled biofilms from gingival fluid of four sites with PPD with 6 mm or more will be collected to evaluate the presence of periodontal pathogens. The samples will be collected from the selected sites and stored in eppendorfs with PBS 1X in -20oC until the microbiological analyses, that will consist in DNA extraction, electroforesis and qualitative polymerase chain reaction (PCR).	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Principal Investigator: Gabriela AC Camargo, Doctor, Fluminense Federal University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): January 26, 2026
• Study Completion (Actual): February 2, 2026

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Laser Therapy; Methylene Blue; Periodontal Diseases; Periodontal Pocket
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Periodontitis; Periodontal Diseases; Periodontal Pocket; Chronic Periodontitis; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Laser Therapy; Phototherapy; Heterocyclic Compounds, 3-Ring; Phenothiazines; Methylene Blue; Saline Solution; Low-Level Light Therapy
• Other Study ID Numbers: 78007624.4.0000.5626

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The result will be communicated verbally to each participant.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No