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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01535690
Enrollment
22
Registered
2012-02-20
Start date
2008-03-31
Completion date
2010-07-31
Last updated
2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERphotodynamic 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.

Sponsors

Escola Bahiana de Medicina e Saude Publica
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
31 Years to 62 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in clinical attachment level1,3, 6 monthsPhotodynamic 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 severe1 and 3 monthsAn improvement in BOP, PD and CAL was observed after treatment, in both groups, but without difference them.

Secondary

MeasureTime frameDescription
changes in clinical attachment level Running title: Photodynamic therapy associated with periodontal debridement Photodynamic th1,3, 6 monthsAn 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026