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

Not Applicable

Recruiting

• Conditions: Periodontitis; Periodontitis, Adult
• Interventions: Procedure: Periodontal treatment

• Registration Number: NCT06426550
• Lead Sponsor: Universidade Federal Fluminense

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.

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 Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-06
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Primary Completion: 2026-02
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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);

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Photobiomodulation with a red laser (PBMV)	Periodontal treatment	After conventional periodontal treatment, photobiomodulation will be performed with a red laser (660 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. As no gel will be applied, the application of the gel with an empty syringe will be simulated, and waited 5 minutes, to keep patients blind to the intervention received.
Photodynamic therapy and 0.005% methylene blue (PDT)	Periodontal treatment	After conventional periodontal treatment, photosensitization will be performed with 0.005% methylene blue gel (Fórmula e Ação Farmácia, São Paulo, SP, Brazil) for 5 minutes, and photodynamic therapy will be applied with a red laser (660 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW.
Saline solution - Control (C)	Periodontal treatment	After conventional periodontal treatment, 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, in order to maintain blinding of the patients.
Photobiomodulation with an infrared laser (PBMIV)	Periodontal treatment	After conventional periodontal treatment, photobiomodulation will be performed with an infrared laser (808 nm) using a DuoⓇ laser (MMOptics, São Carlos, SP, Brazil) with the optical fiber inside the periodontal pocket in back and forth movements, according to the manufacturer's protocol, for 90s, 9 joules of energy, dose of 508.5J/cm2, irradiance of 5.65W/cm2 and power of 100mW. As no gel will be applied, the application of the gel with an empty syringe will be simulated, and waited 5 minutes, to keep patients blind to the intervention received.

Primary Outcome Measures

Name	Time	Method
Gingival recession (GR)	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.
Bleeding on probing (BOP)	Baseline and 3 months	Bleeding on probing (BOP) will be expressed in percentage per individual to evaluate presence of BOP \<20% good results.
Pocket probing depth (PPD)	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.
Plaque index (PI)	Baseline and 3 months	Plaque index will be expressed in percentage per individual to evaluate the supragingival plaque control.
Clinical attachment level (CAL)	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 Outcome Measures

Name	Time	Method
Microbiogical analysis	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).

Trial Locations

Locations (1)

Fluminense Federal University; 🇧🇷 Nova Friburgo, Rio De Janeiro, Brazil