Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 44
- Primary Endpoint
- Clinical attachment level
Study Overview
Brief Summary
The aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.
Detailed Description
Scaling and root planing may be insufficient to resolve the periodontal infection resulting in residual periodontal pockets. A method of treatment to these sites would be the surgical therapy, because it allows access to root surfaces, making possible a better decontamination. However, the surgical approach may bring some negative points, as more discomfort and postoperative morbidity, increased transoperatory risk and increased risk of contamination. Thus, finding other alternatives to residual pockets treatment, antimicrobial photodynamic therapy (aPDT) was recently proposed. Therefore, the aim of this study will be to compare the approach of repeated applications of APDT versus surgical therapy for the treatment of residual pockets in generalized agressive periodontitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
- •Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
- •Present at least one residual pocket of probing depth ≥ 5 mm and bleeding on probe not located in furcation region;
- •Good general health;
- •Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;
Exclusion Criteria
- •Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
- •Have used antibiotics and anti-inflammatories in the last six months;
- •Smoke ≥ 10 cigarettes/day;
- •Pregnant or lactating;
- •Chronic use of medications that may alter the response of periodontal tissues;
- •Indication of antibiotic prophylaxis for dental procedures;
Arms & Interventions
Open flap debridement
In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets.
Intervention: Open flap debridement (Procedure)
Repeated application of aPDT
In this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing.
Intervention: Repeated application of aPDT (Procedure)
Outcomes
Primary Outcomes
Clinical attachment level
Time Frame: 6 months
Secondary Outcomes
- Probing depth(6 months)
Investigators
Mauro Pedrine Santamaria
DDS,MS,PhD
Universidade Estadual Paulista Júlio de Mesquita Filho