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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535690
• Other study ID #: PDTMLB
• Status: Completed
• Phase: N/A
• First received: February 4, 2012
• Last updated: February 17, 2012
• Start date: March 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2012
• Source: Escola Bahiana de Medicina e Saude Publica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 31 Years to 62 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Escola Bahiana de Medicina e Saude Publica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical attachment level	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	1,3, 6 months	Yes
Primary	Photodynamic therapy and periodontitis chronic severe	An improvement in BOP, PD and CAL was observed after treatment, in both groups, but without difference them.	1 and 3 months	Yes
Secondary	changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th	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).	1,3, 6 months	Yes