Comparison Between Surgical Access and Repeated Applications of APDT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial

Conditions
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Aggressive Periodontitis, Generalized

Intervention / Treatment
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* Procedure: Open flap debridement
* Procedure: Repeated application of aPDT


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open flap debridement<br>In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets. | Procedure: Open flap debridement<br>* Open flap debridement will be performed to decontaminate root surface<br>* Other names: Surgical therapy;|
| Active Comparator: Repeated application of aPDT<br>In this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing. | Procedure: Repeated application of aPDT<br>* Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antimicrobial photodynamic therapy, surgical procedure, residual pockets, agressive periodontitis