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NCT Number: NCT06426550

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fluminense Federal University

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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).

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.

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).

Primary outcomes

  1. Plaque index (PI)

    Time frame: Baseline and 3 months

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

  2. Bleeding on probing (BOP)

    Time frame: Baseline and 3 months

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

  3. Pocket probing depth (PPD)

    Time frame: Baseline and 3 months

    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.

  4. Gingival recession (GR)

    Time frame: Baseline and 3 months

    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.

  5. Clinical attachment level (CAL)

    Time frame: Baseline and 3 months

    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.

Secondary outcomes

  1. Microbiogical analysis

    Time frame: Baseline and 3 months

    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).

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 23, 2024
Registry last updated
Feb 27, 2026

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.

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