Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

NCT01034501 | Completed Phase 4

• 1 other identifier: CEP2112008
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological and immunological parameters. This is a randomized, controlled, double-blind, parallel clinical trial. Thirty eight patients with chronic periodontitis will receive conventional periodontal treatment. After eight weeks, patients will be re-evaluated and sites with residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated to test and control group randomly. The test group will receive the application of PDT and the control group will receive sham procedure. The clinical parameters will be evaluated at baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During follow-up, patients will receive periodontal maintenance every 3 months, as well as the application of PDT or sham

Conditions

Chronic Periodontitis

Keywords

periodontitis; photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Change in mean attachment level

  12 months

Secondary Outcomes (3)

• Change in probing pocket depth

  12 months

• Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts.

  12 months

• Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8)

  12 months

Study Arms (2)

photodynamic therapy

ACTIVE COMPARATOR

photodynamic therapy 660 nm,40 mW,60 Hz

Device: photodynamic therapy

sham procedure

SHAM COMPARATOR

Not activation of laser device

Device: sham procedure

Interventions

sham procedure DEVICE

non activated laser tip

Also known as: Laser Hand - MM Optics (ANVISA: 80051420009)

sham procedure

photodynamic therapy DEVICE

photodynamic therapy 660 nm,40 mW,60 Hz

Also known as: Laser Hand - MM Optics (ANVISA: 80051420009)

photodynamic therapy

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Periodontitis (Tonetti, Claffey, 2005)
• or more teeth
• or more site with probing pocket depth ≥ 5 mm, with or without bleeding on probing, after re-evaluation

You may not qualify if:

• Profilatic antibiotics
• Diabetes, immunosuppression, pregnancy nursing mother
• Smoking
• Medication that might interfere with periodontal healing
• Previous periodontal treatment or antibiotics (6 months)
• Experimental teeth with mobility II or III, or endodontic problem

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Faculdade de Odontologia da Universidade de São Paulo (FOUSP)

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (3)

• Christodoulides N, Nikolidakis D, Chondros P, Becker J, Schwarz F, Rossler R, Sculean A. Photodynamic therapy as an adjunct to non-surgical periodontal treatment: a randomized, controlled clinical trial. J Periodontol. 2008 Sep;79(9):1638-44. doi: 10.1902/jop.2008.070652.

  PMID: 18771363 BACKGROUND

• Braun A, Dehn C, Krause F, Jepsen S. Short-term clinical effects of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial. J Clin Periodontol. 2008 Oct;35(10):877-84. doi: 10.1111/j.1600-051X.2008.01303.x. Epub 2008 Aug 17.

  PMID: 18713259 BACKGROUND

• Carvalho VF, Andrade PV, Rodrigues MF, Hirata MH, Hirata RD, Pannuti CM, De Micheli G, Conde MC. Antimicrobial photodynamic effect to treat residual pockets in periodontal patients: a randomized controlled clinical trial. J Clin Periodontol. 2015 May;42(5):440-7. doi: 10.1111/jcpe.12393. Epub 2015 Apr 22.

  PMID: 25808980 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Photochemotherapy

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

Study Officials

• Giorgio De Micheli, Professor

  FOUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: February 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 10, 2013

Record last verified: 2013-10

Locations

BR (1)