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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maybel Lages Balata, Escola Bahiana de Medicina e Saude Publica
ClinicalTrials.gov Identifier:
NCT01535690
First received: February 4, 2012
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Chronic Periodontitis
Other: photodynamic therapy and periodontal debridement

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Escola Bahiana de Medicina e Saude Publica:

Primary Outcome Measures:
  • Change in clinical attachment level [ Time Frame: 1,3, 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 and 3 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1,3, 6 months ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 22
Study Start Date: March 2008
Study Completion Date: July 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   31 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535690

Sponsors and Collaborators
Escola Bahiana de Medicina e Saude Publica
Investigators
Principal Investigator: Maybel Balata, Master Master and Especialist in Periodontics of Bahiana School of Medicine and Public Health, Salvador, BA, Brazil.
  More Information

No publications provided

Responsible Party: Maybel Lages Balata, Master, Escola Bahiana de Medicina e Saude Publica
ClinicalTrials.gov Identifier: NCT01535690     History of Changes
Other Study ID Numbers: PDTMLB
Study First Received: February 4, 2012
Last Updated: February 17, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Escola Bahiana de Medicina e Saude Publica:
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

Additional relevant MeSH terms:
Chronic Periodontitis
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014