Clinical trial NCT01535690: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Escola Bahiana de Medicina e Saude Publica
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 22
Sex: ALL
Minimum age (years): 31
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in clinical attachment level
timeFrame: 1,3, 6 months
measure: Photodynamic therapy and periodontitis chronic severe
timeFrame: 1 and 3 months
Secondary outcomes:
measure: changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th
timeFrame: 1,3, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Master and Especialist in Periodontics of Bahiana School of Medicine and Public Health, Salvador, BA, Brazil.
name: Maybel Balata, Master
role: PRINCIPAL_INVESTIGATOR
References: