Photodynamic Therapy Associated With Full-mouth Ultrasonic Debridement in the Treatment of Severe Chronic Periodontitis

February 17, 2012 updated by: Maybel Lages Balata, Escola Bahiana de Medicina e Saude Publica

Photodynamic Therapy Associated With Full-mouth Ultrasonic Debridement in the Treatment of Severe Chronic Periodontitis: a Randomized-controlled Clinical Trial Running Title: Photodynamic Therapy Associated With Periodontal Debridement

Background: Photodynamic therapy (PDT) is a method of microbial reduction which can benefit periodontal treatment in areas of difficult access, such as deep pockets and furcations. The aim of this randomized controlled clinical trial was to evaluate the effects of PDT as an adjunct to full-mouth ultrasonic debridement in the treatment of severe chronic periodontitis.

Methods: Twenty-two patients with at least one pocket with probing depth (PD) ≥ 7 mm and one pocket with PD ≥ 5 mm and bleeding on probing (BOP) on each side of the mouth were included, characterizing a split mouth design. The control group underwent full-mouth ultrasonic debridement and test group received the same treatment associated with PDT. The following clinical parameters were evaluated: plaque index, gingival index, BOP, gingival recession (GR), PD, and clinical attachment level (CAL). All parameters were collected before, 1, 3 and 6 months after treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The present study was a randomized, blinded, controlled clinical trial, which used a split-mouth design. Prior to commencement, the study design was approved by the Ethics Committee of Bahiana School of Medicine and Public Health (12/2008). All patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

31 years to 62 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of severe chronic periodontitis by the presence of periodontal pockets with clinical attachment loss (CAL) ≥ 5 mm, bleeding on probing (BOP) and radiographic bone loss12;
  • minimum of 2 teeth with probing depth (PD) ≥ 7 mm and 2 other teeth with PD ≥ 5 mm, all with BOP and located on opposite sides of the mouth; and
  • ≥ 16 teeth in both jaws (wisdom teeth excluded).

Exclusion Criteria:

  • periapical alterations on qualifying teeth,
  • systemic diseases that require prophylaxis antibiotic coverage or that could influence progression and response to treatment
  • periodontal treatment in the preceding 6 months,
  • consumption of antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant or calcium channel blocker within the past 3 months; pregnancy;
  • orthodontic therapy,
  • smoking and
  • cardiac pace-makers users

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: laser and methilene blue
After random allocation, all patients received full-mouth ultrasonic debridement using an ultrasonic scaler (Profi III Bios, Dabi Atlante, Ribeirão Preto, São Paulo, Brazil) for 1 hour. Specific tips were used (Perio sub, Dabi Atlante, Ribeirão Preto, São Paulo, Brazi). PDT was performed on only one side of the mouth and the initial step was subgingival irrigation with 0.005% methylene blue dye. To avoid contamination of the control sites with the dye, the methylene blue was applied only inside the periodontal pockets and a high-powered suction device controlled the flow. Two minutes after applying the photosensitizer, the low power laser - AsGaAl (Photon Laser III - PL7336, DMC, São Carlos -São Paulo, Brazil) was applied (660 nm, 100 mW, 9 J, 90 seconds per site, 320 J/cm2).
Other: photodynamic therapy and periodontal debridement
At least two teeth (one with PD ≥ 7 mm and another with PS ≥ 5 mm) were randomly assigned (by coin toss) to one of the treatments: with (test group) or without PDT (control group). After random allocation, all patients received full-mouth ultrasonic debridement using an ultrasonic scaler for 1 hour. Specific tips were used. PDT was performed on only one side of the mouth and the initial step was subgingival irrigation with 0.005% methylene blue dye. To avoid contamination of the control sites with the dye, the methylene blue was applied only inside the periodontal pockets and a high-powered suction device controlled the flow. Two minutes after applying the photosensitizer, the low power laser - AsGaAl was applied for 90 seconds.
Other Names:
  • debridement using an ultrasonic scaler
  • Specific tips were used
  • 0.005% methylene blue dye
  • low power laser - AsGaAl

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in clinical attachment level
Time Frame: 1,3, 6 months
Photodynamic therapy associated with full-mouth ultrasonic debridement in the treatment of severe chronic periodontitis: a randomized-controlled clinical trial Running title: Photodynamic therapy associated with periodontal debridement
1,3, 6 months
Photodynamic therapy and periodontitis chronic severe
Time Frame: 1 and 3 months
An improvement in BOP, PD and CAL was observed after treatment, in both groups, but without difference them.
1 and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th
Time Frame: 1,3, 6 months
An improvement in BOP, PD and CAL was observed after treatment, in both groups, but without difference them. After 6 months, PD decreased from 5.11 ± 0.56 mm to 2.83 ± 0.47 mm in test group (p<0.05) and from 5.15 ± 0.46 mm to 2.83 ± 0.40 mm in control group (p<0.05). The CAL changed, after 6 months, from 5.49 ± 0.76 mm to 3.41 ± 0.84 mm in th test group (p<0.05) and from 5.53 ± 0.54 to 3.39 ± 0.51 mm in control group (p<0.05).
1,3, 6 months

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Escola Bahiana de Medicina e Saude Publica

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maybel Balata, Master, Master and Especialist in Periodontics of Bahiana School of Medicine and Public Health, Salvador, BA, Brazil.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDTMLB

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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