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Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy

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ClinicalTrials.gov Identifier: NCT03142776
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:
To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis, Generalized Procedure: periodontal debridement Procedure: photodynamic therapy Drug: systemic clarithromycin Not Applicable

Detailed Description:
The aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; PD+PDT (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. Probing depth (PD),gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Local Effect of Nonsurgical Periodontal Treatment of Generalized Aggressive Periodontitis Associated or Not With Systemic Antibiotics and Photodynamic Therapy.: a Randomized Clinical Trial
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Placebo Comparator: Periodontal debridement
Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
Procedure: periodontal debridement
Other Name: Ultrassonic periodontal debridement

Active Comparator: Periodontal debridement + CLM
Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days.
Procedure: periodontal debridement
Other Name: Ultrassonic periodontal debridement

Drug: systemic clarithromycin
Other Name: antibiotic

Active Comparator: Periodontal debridement + PDT
Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy).
Procedure: periodontal debridement
Other Name: Ultrassonic periodontal debridement

Procedure: photodynamic therapy
Other Name: antimicrobial photodynamic therapy

Active Comparator: Periodontal debridement + CLM + PDT
Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT.
Procedure: periodontal debridement
Other Name: Ultrassonic periodontal debridement

Procedure: photodynamic therapy
Other Name: antimicrobial photodynamic therapy

Drug: systemic clarithromycin
Other Name: antibiotic




Primary Outcome Measures :
  1. Clinical attachment level [ Time Frame: 6 months ]
    distance from bottom of pocket to the cement-enamel junction


Secondary Outcome Measures :
  1. Probing depth [ Time Frame: 6 months ]
    distance from the bottom of sulcus/pocket to gingival margin



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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 GagP
  • presence of ≥20 teeth
  • <35 years of age
  • periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - agree to participate in the study and sign a written consent.

Exclusion Criteria:

  • pregnant or lactating
  • suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
  • received antimicrobials in the previous 6 months
  • taking long-term anti-inflammatory drugs
  • received a course of periodontal treatment within the last 12 months
  • smoked

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): NCT03142776


Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Study Director: Mauro P Santamaria, DDS, PhD UPECLIN HC FM Botucatu Unesp

Publications:
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Responsible Party: Mauro Pedrine Santamaria, PhD, Adjunct professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03142776     History of Changes
Other Study ID Numbers: CLMPDT
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: March 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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
clarithromycin
photodynamic therapy
Antimicrobial therapy
Periodontal pocket

Additional relevant MeSH terms:
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Periodontitis
Aggression
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Anti-Bacterial Agents
Clarithromycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors