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Comparison Between Surgical Access and Repeated Applications of APDT

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ClinicalTrials.gov Identifier: NCT03140059
Recruitment Status : Unknown
Verified October 2017 by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho.
Recruitment status was:  Active, not recruiting
First Posted : May 4, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis, Generalized Procedure: Open flap debridement Procedure: Repeated application of aPDT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Active Comparator: Open flap debridement
In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets.
Procedure: Open flap debridement
Open flap debridement will be performed to decontaminate root surface
Other Name: Surgical therapy

Active Comparator: Repeated application of aPDT
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
Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.




Primary Outcome Measures :
  1. Clinical attachment level [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Probing depth [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140059


Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Study Director: Mauro P Santamaria, DDS, PhD Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
Publications:
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Responsible Party: Mauro Pedrine Santamaria, DDS,MS,PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03140059    
Other Study ID Numbers: SurgeryPDT
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
surgical procedure
residual pockets
agressive periodontitis
antimicrobial photodynamic therapy
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms