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Trial record 6 of 7 for:    "Acute Pericementitis" | "Antiparasitic Agents"

Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

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ClinicalTrials.gov Identifier: NCT02839421
Recruitment Status : Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Carlos Martin Ardila Medina, Facultad Nacional de Salud Publica

Brief Summary:
The aim of the present study is to evaluate the clinical and microbiological efficacy of moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in treating generalized aggressive periodontitis. Forty five subjects will be randomly allocated to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable bacteria. The primary outcome variable to determine the superiority of one treatment over the others would be differences between groups for means CAL changes at 6 months post-treatment. Secondary outcome variables include differences between therapies for the mean changes in the mean levels of PD and the proportion of BOP.

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Drug: Scaling and Root Planing combined with moxifloxacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Moxifloxacin, Amoxicillin+Metronidazole for Aggressive Periodontitis Treatment
Study Start Date : December 2015
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Scaling and Root Planing plus moxifloxacin
The interventions are Scaling and Root Planing (SRP) combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days.The experimental treatment group consist of SRP combined with systemically administered MOX at the dosage of 400 mg once daily for 7 days.One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The adjunctive agent will start at the SRP visit. Subjects in the MOX group will be extensively informed about the intake of the prescribed medication.
Drug: Scaling and Root Planing combined with moxifloxacin
Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days
Other Name: periodontal scaling

Active Comparator: Scaling and Root Planing plus amox-metro

The active comparator is Scaling and Root Planing (SRP) combined with systemically administered Amoxicillin (amox) + Metronidazole (metro) 500 mg tid each one for 7 days. The active comparator group consist of SRP combined with systemically administered Amoxicillin (amox) + Metronidazole (metro) 500 mg tid each one for 7 days.

One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The adjunctive agent will start at the SRP visit. Subjects in the amox-metro group will be extensively informed about the intake of the prescribed medication.

Drug: Scaling and Root Planing combined with moxifloxacin
Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days
Other Name: periodontal scaling

Placebo Comparator: Scaling and Root Planing plus placebo
Scaling and Root Planing (SRP) + placebo once daily for 7 days. The placebo comparator group consist of SRP combined with systemically administered placebo once daily for 7 days. One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The placebo agent will start at the SRP visit. Subjects in the placebo group will be extensively informed about the intake of the prescribed medication.
Drug: Scaling and Root Planing combined with moxifloxacin
Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days
Other Name: periodontal scaling




Primary Outcome Measures :
  1. clinical attachment level [ Time Frame: 3 and 6 months ]
    It was defined that the primary outcome variable to determine the superiority of one treatment over the other would be differences between groups for means Clinical Attachment Level changes at 6 months post-treatment. This is a measure assessing change between two time points .



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects ≤30 years of age
  • minimum of six permanent teeth, with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and a minimum of six teeth other than first molars and incisors with at least one site each with PD and CAL ≥5 mm.

Exclusion Criteria:

  • diabetes
  • cardiovascular diseases
  • immunological disorders or any other systemic disease that could alter the course of periodontal disease.
  • Pregnant or nursing women
  • smoking
  • allergy to amoxicillin, metronidazole, fluoroquinolones or moxifloxacin
  • consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months
  • periodontal therapy during the last 6 months

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): NCT02839421


Locations
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Colombia
Faculty of Dentistry
Medellín, Antioquia, Colombia
Sponsors and Collaborators
Facultad Nacional de Salud Publica

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Responsible Party: Carlos Martin Ardila Medina, Titular Professor, Facultad Nacional de Salud Publica
ClinicalTrials.gov Identifier: NCT02839421     History of Changes
Other Study ID Numbers: 003
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Aggressive Periodontitis
Antiparasitic Agents
Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Amoxicillin
Moxifloxacin
Metronidazole
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antiprotozoal Agents