Skip to main content
Clinical Trials/NCT01535690
NCT01535690
Completed
Not Applicable

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

Escola Bahiana de Medicina e Saude Publica0 sites22 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Periodontitis
Sponsor
Escola Bahiana de Medicina e Saude Publica
Enrollment
22
Primary Endpoint
Change in clinical attachment level
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
July 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Escola Bahiana de Medicina e Saude Publica
Responsible Party
Principal Investigator
Principal Investigator

Maybel Lages Balata

Master

Escola Bahiana de Medicina e Saude Publica

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

Outcomes

Primary Outcomes

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

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

  • changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th(1,3, 6 months)

Similar Trials