Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP).


Clinical Trial Description

The study methodology is according to CONSORT-STATEMENT 2010 for randomized controlled clinical trials. Study Design The study is designed as a prospective, interventional, parallel, triple blind, randomized, controlled clinical trial aimed to assess the clinical outcomes of full-mouth ultrasonic debridement combined with clarithromycin or amoxicillin + metronidazole association for the treatment of generalized aggressive periodontitis (GAgP). The study was approved by Institute of Science and Technology's (ICT - State University of São Paulo) Ethics Committee (protocol 1.079.307). Source of data The population of this study will be recruited among patients referred to the Science and Technology Institute - ICT- São José dos Campos, College of Dentistry. Patients will fill a healthy history questionnaire to ensure that they are medically qualified for participate in this study. Based on the power calculation for this study, 44 subjects divided into two groups will be needed to achieve 80% power to detect a 0.8 mm difference in the clinical attachment level (CAL) of patients. Clinical Parameters All clinical parameters will be assessed by a single blinded, trained and calibrated examiner (CFA) before periodontal therapy (baseline) and at 3 and 6 months after using a manual probe. Measurements will be done at six sites per tooth (mesiobuccal, buccal, disto-buccal, distolingual, lingual, and mesiolingual) in all teeth, except third molars. The following clinical parameters will be evaluated: 1) Full-mouth plaque index (FMPI); 2) Bleeding on probing (BoP); 3) Probing depth (PD): distance from the bottom of sulcus/pocket to gingival margin; 4) Gingival recession (GM): distance from the free gingival margin to cement-enamel junction (CEJ); 5) Clinical attachment level (CAL): distance from bottom of sulcus/pocket to the CEJ. The CEJ will be identified by careful probe on cervical area. Calibration and Randomization Initially, a total of ten patients presenting with GAgP will be selected. The designated examiner (CFA) will measure CAL and PD in all patients twice within 24 hours, with an interval of ≥ 1 hour between examinations. Then, the measures will be submitted to intraclass correlation test and the examiner will be judged calibrated if reaches 90% agreement. Patients will be allocated into two groups according to a computer-generated list. The allocation will be implemented by an investigator (NCCS) who was not directly involved in the examination or treatment procedures. All medication will be prepared and encased in identical opaque coded bottles by a manipulation pharmacy on São José dos Campos/São Paulo. Treatment Protocols All patients will be treated with periodontal therapy through of the one-stage, full mouth, ultrasonic debridement (FMUD). In a single session, patients will receive local anesthesia and periodontal debridement with ultrasound equipment (Cavitron - Dentsply EUA) and subgingival tips (UI25KSF10S, Hu-Friedy). All diseased sites will be instrumented in this one session. The debridement session will be performed by a single experienced and trained periodontist (MPS), different from the examiner. Immediately before the mechanical therapy, patients will be allocated in one of the two treatment protocols: 1. Clarithromycin (CLM) group (n = 22): FMUD + CLM 500 mg bid, for 7 days and 2. Amoxicillin (AMX) + metronidazole (MET) group (n = 22): FMUD + (AMX 500 mg tid + MET 400 mg tid, both for 7 days. All patients will start taking the pills immediately before of the FMUD session. Compliance and Adverse Effects After 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented. Moreover, patients will be instructed to return a self-report form filled about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen. Statistical analysis Mean and standard deviation will be calculated for each parameter. The normal distribution of the data will be analyzed by Shapiro-Wilk test. Data from clinical measurements will be subjected to analysis of variance (repeated measures) for inter and intra-group comparison. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02969928
Study type Interventional
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact
Status Completed
Phase Phase 2/Phase 3
Start date March 2015
Completion date December 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05043935 - The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis N/A
Terminated NCT01993368 - Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis N/A
Completed NCT02282800 - Immunolocalization of 1,25,Dihydroxyvitamin D3 in Aggressive Periodontitis Patients N/A
Recruiting NCT02833285 - B Cell Functions in Periodontitis
Completed NCT02127203 - Nitro-oxidative Stress in Periodontitis N/A
Completed NCT02223702 - Alternative Antibiotic Regime in the Treatment of GAgP Phase 4
Completed NCT03093207 - Omega-3 Fatty Acids Plus Low-dose Aspirin Daily Supplementation in Surgical Therapy to Treat Aggressive Periodontitis Phase 2/Phase 3
Completed NCT03093246 - Omega-3 Plus Low-dose Aspirin Daily Supplementation in Non-surgical Therapy to Treat Aggressive Periodontitis Phase 2/Phase 3
Completed NCT05295576 - Effect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis Patients
Completed NCT05297084 - Non Surgical Periodontal Treatment Effect on Il-17 and Il-18 in Aggressive Periodontitis
Completed NCT02829983 - Clarithromycin as Adjuvant to Periodontal Debridement N/A
Completed NCT02927704 - Gingival Crevicular Fluid Levels Of Monocyte Chemoattractant Protein-1 N/A
Completed NCT02817568 - Frequency Of MCP-1 And CCR2 Gene Polymorphisms And Its Effect On Gene Expression In Patients With AgP N/A
Active, not recruiting NCT04051255 - Influence of Smoking on Clinical, Microbiological and Immunologic Parameters in Patients With Aggressive Periodontitis. N/A
Completed NCT05001919 - Concentrated Growth Factors in Treatment of Intrabony Defects in Localized Aggressive Periodontitis Phase 1/Phase 2
Completed NCT03727620 - Doxycycline in the Treatment of Aggressive Periodontitis Phase 1/Phase 2
Completed NCT04223869 - IL-34 Levels in Various Types of Periodontitis N/A
Completed NCT03034824 - Effects of Er,Cr:YSGG, Diode Lasers on GCF Cytokines Levels N/A
Completed NCT02049008 - Treatment of Aggressive Periodontitis With Repeated Adjunctive Antimicrobial Photodynamic Therapy Phase 4
Recruiting NCT01510808 - The Affect of Orthodontic Treatment on the Periodontal Status of Patients With Aggressive Periodontitis N/A