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

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Other: photodynamic therapy and periodontal debridement

• Registration Number: NCT01535690
• Lead Sponsor: Escola Bahiana de Medicina e Saude Publica

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-10
• Study Completion: 2010-07
• Status Verified: 2012-02
• Study First Submitted: 2012-02-04
• Study First Submitted QC: 2012-02-17
• Last Update Submitted: 2012-02-17
• Study First Posted: 2012-02-20
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laser and methilene blue	photodynamic therapy and periodontal debridement	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).

Primary Outcome Measures

Name	Time	Method
Change in clinical attachment level	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	1 and 3 months	An improvement in BOP, PD and CAL was observed after treatment, in both groups, but without difference them.

Secondary Outcome Measures

Name	Time	Method
changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th	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).