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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
History of Changes

February 4, 2012
February 17, 2012
March 2008
October 2009   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01535690 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Photodynamic Therapy Associated With Full-mouth Ultrasonic Debridement in the Treatment of Severe Chronic Periodontitis
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.

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.
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Chronic Periodontitis
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
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).
Intervention: Other: photodynamic therapy and periodontal debridement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
July 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
31 Years to 62 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01535690
PDTMLB
Yes
Maybel Lages Balata, Escola Bahiana de Medicina e Saude Publica
Escola Bahiana de Medicina e Saude Publica
Not Provided
Principal Investigator: Maybel Balata, Master Master and Especialist in Periodontics of Bahiana School of Medicine and Public Health, Salvador, BA, Brazil.
Escola Bahiana de Medicina e Saude Publica
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP