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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
photodynamic therapy and periodontal debridement
Sponsored by
Escola Bahiana de Medicina e Saude Publica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Laser, Clinical trial, Non-surgical periodontal therapy, Periodontitis, bleeding on probing and radiographic bone loss, minimum of 2 teeth with probing depth (PD) ≥ 7 mm and, 2 other teeth with PD ≥ 5 mm, mininum 16 teeth in both jaws

Eligibility Criteria

31 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    laser and methilene blue

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    Change in clinical attachment level
    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
    Photodynamic therapy and periodontitis chronic severe
    An improvement in BOP, PD and CAL was observed after treatment, in both groups, but without difference them.

    Secondary Outcome Measures

    changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th
    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).

    Full Information

    First Posted
    February 4, 2012
    Last Updated
    February 17, 2012
    Sponsor
    Escola Bahiana de Medicina e Saude Publica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01535690
    Brief Title
    Photodynamic Therapy Associated With Full-mouth Ultrasonic Debridement in the Treatment of Severe Chronic Periodontitis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Escola Bahiana de Medicina e Saude Publica

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    Laser, Clinical trial, Non-surgical periodontal therapy, Periodontitis, bleeding on probing and radiographic bone loss, minimum of 2 teeth with probing depth (PD) ≥ 7 mm and, 2 other teeth with PD ≥ 5 mm, mininum 16 teeth in both jaws

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    N/A
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    laser and methilene blue
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    photodynamic therapy and periodontal debridement
    Other Intervention Name(s)
    debridement using an ultrasonic scaler, Specific tips were used, 0.005% methylene blue dye, low power laser - AsGaAl
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in clinical attachment level
    Description
    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
    Time Frame
    1,3, 6 months
    Title
    Photodynamic therapy and periodontitis chronic severe
    Description
    An improvement in BOP, PD and CAL was observed after treatment, in both groups, but without difference them.
    Time Frame
    1 and 3 months
    Secondary Outcome Measure Information:
    Title
    changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th
    Description
    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).
    Time Frame
    1,3, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    31 Years
    Maximum Age & Unit of Time
    62 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maybel Balata, Master
    Organizational Affiliation
    Master and Especialist in Periodontics of Bahiana School of Medicine and Public Health, Salvador, BA, Brazil.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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