Back to resultsComparison Between Surgical Access and Repeated Applications of APDT
Primary Purpose
Aggressive Periodontitis, Generalized
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open flap debridement
Repeated application of aPDT
Sponsored by
About this trial
This is an interventional treatment trial for Aggressive Periodontitis, Generalized focused on measuring surgical procedure, residual pockets, agressive periodontitis, antimicrobial photodynamic therapy
Eligibility 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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Open flap debridement
Repeated application of aPDT
Arm Description
In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets.
In this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing.
Outcomes
Primary Outcome Measures
Clinical attachment level
Secondary Outcome Measures
Probing depth
Full Information
NCT ID
NCT03140059
First Posted
May 2, 2017
Last Updated
October 16, 2017
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
1. Study Identification
Unique Protocol Identification Number
NCT03140059
Brief Title
Comparison Between Surgical Access and Repeated Applications of APDT
Official Title
Comparison Between Surgical Access and Repeated Applications of APDT to Residual Pockets Treatment in Generalized Aggressive Periodontitis: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Periodontitis, Generalized
Keywords
surgical procedure, residual pockets, agressive periodontitis, antimicrobial photodynamic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open flap debridement
Arm Type
Active Comparator
Arm Description
In this group (n = 22), patients will receive open flap debridement will be performed to treat residual pockets.
Arm Title
Repeated application of aPDT
Arm Type
Active Comparator
Arm Description
In this group (n=22), patients will receive 5 applications of antimicrobial photodynamic therapy after the scaling and root planing.
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement
Other Intervention Name(s)
Surgical therapy
Intervention Description
Open flap debridement will be performed to decontaminate root surface
Intervention Type
Procedure
Intervention Name(s)
Repeated application of aPDT
Intervention Description
Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.
Primary Outcome Measure Information:
Title
Clinical attachment level
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Probing depth
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro P Santamaria, DDS, PhD
Organizational Affiliation
Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19563331
Citation
Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.
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Comparison Between Surgical Access and Repeated Applications of APDT
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