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

May 4, 2017 updated by: Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Ultrassonic periodontal debridement
Drug: systemic clarithromycin
Other Names:
  • 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: photodynamic therapy
Other Names:
  • antimicrobial photodynamic therapy
Procedure: periodontal debridement
Other Names:
  • Ultrassonic periodontal debridement
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: photodynamic therapy
Other Names:
  • antimicrobial photodynamic therapy
Procedure: periodontal debridement
Other Names:
  • Ultrassonic periodontal debridement
Drug: systemic clarithromycin
Other Names:
  • antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level
Time Frame: 6 months
distance from bottom of pocket to the cement-enamel junction
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: 6 months
distance from the bottom of sulcus/pocket to gingival margin
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (ACTUAL)

May 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLMPDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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