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NCT Number: NCT01535690

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

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

31 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

photodynamic therapy and periodontal debridement

Other

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Escola Bahiana de Medicina e Saude Publica

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Feb 20, 2012
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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