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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426550
• Other study ID #: 78007624.4.0000.5626
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Universidade Federal Fluminense
• Contact: Gabriela AC Camargo, PhD
• Phone: 12981815874
• Email: gabrielacruz[@]id.uff.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontal Diseases
• Periodontitis
• Periodontitis, Adult

Intervention

Procedure:
• Periodontal treatment
An experienced periodontist will access clinical periodontal parameters, including plaque index, bleeding on probing, pocket probing depth, gingival recession, clinical attachment level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars. Conventional periodontal treatment, scaling and root planning, will be performed with ultrasound (Dabi Atlante, Rio de Janeiro, RJ, Brazil) complemented with Gracey curettes (Golgran, São Caetano do Sul, SP, Brazil) on each patient under local anesthesia. The maintenance therapy will include professional plaque control and scaling and root planning in recurrent periodontal pockets, every 30 days, until 3 months, when the periodontal parameters will be reassessed.

Locations

Country	Name	City	State
Brazil	Fluminense Federal University	Nova Friburgo	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque index (PI)	Plaque index will be expressed in percentage per individual to evaluate the supragingival plaque control.	Baseline and 3 months
Primary	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
Primary	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
Primary	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
Primary	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	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