Evaluation of Antimicrobial Photodynamic Therapy in Multiple Applications as a Coadjuvant in the Surgical Therapy of Access to Scaling

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03498404
• Date of registration: 07/04/2018
• Prospective Registration: Yes
• Primary sponsor: University of Sao Paulo
• Public title: Evaluation of Antimicrobial Photodynamic Therapy in Multiple Applications as a Coadjuvant in the Surgical Therapy of Access to Scaling
• Scientific title: Evaluation of Antimicrobial Photodynamic Therapy in Multiple Applications as a Coadjuvant in the Surgical Therapy of Access to Scaling in Patients With Advanced Chronic Periodontitis
• Date of first enrolment: April 7, 2018
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03498404
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Brazil

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with >35 years old

- A minimum of 15 teeth present

- One pair of posterior teeth in opposite sides with proximal sites showing probing
depth and clinical attachment level = 5 mm.

Exclusion Criteria:

- Positive history of antibiotic-therapy in the last six months

- Positive history of basic periodontal treatment in the last six months

- Systemic disease that can interfere with the progression of disease or response to
treatment (eg, diabetes, immune disorders)

- Extensive prosthetic involvement

- Need for antibiotic prophylaxis for performing routine dental procedures

- Use of anti-inflammatory drugs for long periods of time

- Smoking

- Pregnancy



Age minimum: 35 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Periodontitis

Intervention(s)

Radiation: Photodynamic Therapy

Other: scaling and root planing

Primary Outcome(s)

to evaluate clinical attachment level [Time Frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +120 days after the surgical periodontal therapy.]

Secondary Outcome(s)

counts of 40 subgingival bacterial species [Time Frame: Microbiological monitoring (at baseline and +30 and +120 days after the surgical periodontal therapy) using the checkerboard DNA-DNA hybridization]

patients requiring additional periodontal treatment [Time Frame: Considering each group separately, it will be evaluate the number of patients presenting at least a site with PPD=5 mm and positiveBOP at 120 days post-therapy]

Secondary ID(s)

58437816.3.0000.5419

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Uislen Berian Cadore