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

NCT01535690 | Completed DMC

• 1 other identifier: PDTMLB
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th

  1,3, 6 months

Study Arms (1)

laser and methilene blue

EXPERIMENTAL

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).

Other: photodynamic therapy and periodontal debridement

Interventions

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.

Also known as: debridement using an ultrasonic scaler, Specific tips were used, 0.005% methylene blue dye, low power laser - AsGaAl

laser and methilene blue

Eligibility Criteria

• Age: 31 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Escola Bahiana de Medicina e Saude Publica: lead

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Photochemotherapy; Periodontal Debridement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Dental Prophylaxis; Periodontics; Dentistry

Study Officials

• Maybel Balata, Master

  Master and Especialist in Periodontics of Bahiana School of Medicine and Public Health, Salvador, BA, Brazil.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: February 4, 2012
• First Posted: February 20, 2012
• Study Start: March 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: July 1, 2010
• Last Updated: February 20, 2012

Record last verified: 2012-02