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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Radiation: Photodynamic Therapy Other: scaling and root planing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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
- 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
- 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.
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
|University of Sao Paulo|
|São Paulo, Sao Paulo, Brazil, 14040-904|