Clinical trial NCT06426550: Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV
Official title: Clinical and Microbiological Evaluation of Laser Therapy in the Treatment of Periodontal Disease in Stages III and IV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Periodontitis, Adult
Keywords: Periodontal Diseases
Periodontal Pocket
Laser Therapy
Methylene Blue
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Clinical, laboratory, longitudinal split-mouth study carried out in humans.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plaque index (PI)
timeFrame: Baseline and 3 months
measure: Bleeding on probing (BOP)
timeFrame: Baseline and 3 months
measure: Pocket probing depth (PPD)
timeFrame: Baseline and 3 months
measure: Gingival recession (GR)
timeFrame: Baseline and 3 months
measure: Clinical attachment level (CAL)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Microbiogical analysis
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Nova Friburgo
country: Brazil
facility: Fluminense Federal University
state: Rio de Janeiro
Study officials:
affiliation: Fluminense Federal University
name: Gabriela AC Camargo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.