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Evaluation of Antimicrobial Photodynamic Therapy in Multiple Applications as a Coadjuvant in the Surgical Therapy of Access to Scaling

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ClinicalTrials.gov Identifier: NCT03498404
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Uislen Berian Cadore
Information provided by (Responsible Party):
Sergio Luis Scombatti de Souza, University of Sao Paulo

Brief Summary:
Chronic periodontitis is an infectious disease resulting in inflammation of the teeth support structures, progressive periodontal attachment loss and bone loss. The aim of this study is to evaluate the effects of antimicrobial photodynamic therapy (TFDA) in multiple applications as an adjunct to surgical periodontal therapy in patients with generalized severe chronic periodontitis. A total of twenty patients will be submitted to this split-mouth trial, receiving initial periodontal basic nonsurgical treatment that is scaling and root planing. After the sites are indicated for surgical therapy, they receive surgical access therapy associated with scaling and root planing and TfdA using the treatment protocol during periods of 0, 7, 14 and 30 postoperative days, or only surgical access therapy associated with scaling and root planing. As protocol, TfdA will be used laser light source 660nm wavelength in combination with phenothiazine, a photosensitizer with 10 seconds of exposure per site during surgery and 60 seconds in other applications. All patients will be oral hygiene care and follow-up for 90 days. In the baseline period, basic post-therapy, 30 and 90 days after surgical therapy will be performed the clinical evaluation of plaque index, depth of probing pocket, level of clinical insertion relative and bleeding on probing, beyond the collection plate samples subgingival 40 for counting microbial species using the method of DNA-DNA hybridization checkerboard. For the same periods are also collected samples of gingival crevicular fluid for evaluating fluid volume (Periotron) and the levels of Interleukin 1 beta, Interleukin 10, MMP-8, tumor necrosis factor alpha, RANK-L and Osteoprotegerin (OPG). The data are statistically analyzed with the tests to the sample.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Radiation: Photodynamic Therapy Other: scaling and root planing Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Antimicrobial Photodynamic Therapy in Multiple Applications as a Coadjuvant in the Surgical Therapy of Access to Scaling in Patients With Advanced Chronic Periodontitis
Actual Study Start Date : April 7, 2018
Actual Primary Completion Date : April 7, 2018
Actual Study Completion Date : April 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Photodynamic Therapy and SRP

Procedure/Surgery: Photodynamic Therapy After a surgical access, the periodontal pockets of teeth selected to receive antimicrobial photodynamic therapy (aPDT) will be irrigated with distilled water. Shortly thereafter, the dye will be applied (phenothiazine hydrochloride- 10mg/mL) from the bottom of the pocket. After 1 minute, irrigation will be performed with distilled water to remove the excess of dye. The stained area will be irradiated with a diode laser (660 nm and a 60 mW/cm²). Six sites per tooth under treatment will be irradiated (10 seconds/ site). Teeth with furcation lesion will increase over 60 seconds into the lesion. Before the application, the supragingival plaque will be removed.

Treatment with TFDa in the Test Group maintained the protocol of applications in the periods of 2, 7 and 14 days post-surgical intervention.

Radiation: Photodynamic Therapy
After the sites are indicated for surgical therapy, they receive surgical access therapy associated with scaling and root planing and TfdA using the treatment protocol during periods of 0, 7, 14 and 30 postoperative days, or only surgical access therapy associated with scaling and root planing. As protocol, TfdA will be used laser light source 660nm wavelength in combination with phenothiazine, a photosensitizer with 10 seconds of exposure per site during surgery and 60 seconds in other applications.

Sham Comparator: SRP and Sham Photodynamic Therapy
Procedure/Surgery: Sham Photodynamic Therapy After a surgical access, the periodontal pockets of teeth selected will receive a simulation of antimicrobial photodynamic therapy (aPDT): irrigation with distilled water and simulated laser application. Before the application, the supragingival plaque will be removed.
Other: scaling and root planing
Scaling and root planing, also known as conventional periodontal therapy, or deep cleaning, is a procedure involving removal of dental plaque and calculus (scaling or debridement) and then smoothing, or planing, of the (exposed) surfaces of the roots, removing cementum or dentine that is impregnated with calculus, toxins, or microorganisms, the etiologic agents that cause inflammation. This helps to establish a periodontium that is in remission of periodontal disease. Periodontal scalers and periodontal curettes are some of the tools involved.




Primary Outcome Measures :
  1. to evaluate clinical attachment level [ Time Frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +120 days after the surgical periodontal therapy. ]
    Change from Baseline in clinical attachment level at +120 days


Secondary Outcome Measures :
  1. counts of 40 subgingival bacterial species [ Time Frame: Microbiological monitoring (at baseline and +30 and +120 days after the surgical periodontal therapy) using the checkerboard DNA-DNA hybridization ]
    Change from baseline in counts of 40 subgingival bacterial species at +30 and +120 days

  2. patients requiring additional periodontal treatment [ Time Frame: Considering each group separately, it will be evaluate the number of patients presenting at least a site with PPD≥5 mm and positiveBOP at 120 days post-therapy ]
    Numbers of patients requiring additional periodontal treatment at +120 days.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with >35 years old
  • A minimum of 15 teeth present
  • One pair of posterior teeth in opposite sides with proximal sites showing probing depth and clinical attachment level ≥ 5 mm.

Exclusion Criteria:

  • Positive history of antibiotic-therapy in the last six months
  • Positive history of basic periodontal treatment in the last six months
  • Systemic disease that can interfere with the progression of disease or response to treatment (eg, diabetes, immune disorders)
  • Extensive prosthetic involvement
  • Need for antibiotic prophylaxis for performing routine dental procedures
  • Use of anti-inflammatory drugs for long periods of time
  • Smoking
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498404


Locations
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Brazil
University of Sao Paulo
São Paulo, Sao Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
Uislen Berian Cadore

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Responsible Party: Sergio Luis Scombatti de Souza, Dr, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03498404     History of Changes
Other Study ID Numbers: 58437816.3.0000.5419
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Anti-Bacterial Agents