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Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes

Primary Purpose

Periodontitis, Periodontal Pocket, Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Amoxicillin 500 mg / Metronidazole 250 mg
Clindamycin 300 mg
Sponsored by
Centro Universitario de Tonalá
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, diabetes mellitus, systemic antimicrobials

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of both sexes
  • Age >18 to 70 years
  • Diagnosis of chronic periodontitis according to the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions
  • History of type 2 diabetes
  • HbA1C < 8 %
  • Fasting plasma glucose (FPG) < 180 mg/dL.

Exclusion Criteria:

  • Aggressive periodontitis
  • Pregnant or lactating females,
  • Required antibiotic pre-medication for the performance of periodontal examination and treatment or received antibiotic treatment in the previous 3 months were excluded.
  • A history of anti-inflammatory therapy within preceding six months
  • Had received a course of periodontal treatment within the last 6 months,
  • Allergies to penicillin, metronidazole or clindamycin,
  • Not able to provide consent to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    AMX-MET

    Clindamycin

    Arm Description

    AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules. 1 capsule tid during 7 days.

    Clindamycin Clindamycin 300 mg + placebo. Capsules. 1 capsule tid during 7 days.

    Outcomes

    Primary Outcome Measures

    Probing Depth
    The size of the periodontal pocket

    Secondary Outcome Measures

    Sites With Plaques
    0: no plaque separate flecks of plaque at the cervical margin of the tooth a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth a continuous band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth plaque covering at least one-third but less than two-thirds of the crown of the tooth plaque covering two-thirds or more of the crown of the tooth. A higher scores mean a worse outcome
    Sites With Bleeding on Probing
    Refers to bleeding on probing 0: absence of inflammation mild inflammation; a slight change in color, little change in the texture of any portion of but not the entire marginal or papillary gingival unit mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4; severe inflammation; marked redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
    Total Count of All Teeth Lost Across All Participants
    The total count of all teeth lost in all participants.

    Full Information

    First Posted
    December 12, 2017
    Last Updated
    September 15, 2020
    Sponsor
    Centro Universitario de Tonalá
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03374176
    Brief Title
    Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes
    Official Title
    Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in the Treatment of Periodontitis in Patients With Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro Universitario de Tonalá

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Periodontitis is an inflammation of the supporting structures of the teeth, usually caused by specific or groups of microorganisms that results in the progressive destruction of the periodontal ligament and alveolar bone. the objective of periodontitis treatment is to reduce the number of periodontal pathogens. However, there is not an agreement in the use of systemic antibiotics in patients with diabetes. The purpose of the present study was to determine the efficacy of amoxicillin/metronidazole compared to clindamycin during non-surgical treatment of periodontitis in patients with type 2 diabetes mellitus. Patients and methods In this double-blind, randomized clinical trial, a total of 42 patients with chronic periodontitis and type 2 diabetes were included in a 24-months follow-up. Patients were randomly assigned to treatment with either amoxicillin/metronidazole or clindamycin every for 7 days. Clinical determinations (depth of probing, bleeding at the probe and plaque index) were performed to determine the extent and severity of periodontitis before and after the pharmacological treatment. The intra-group differences were calculated with Wilcoxon rank test. The inter-group differences were calculated with Mann-Whitney test. Sex, bacterial plaque, and bleed to the sounding were summarized using proportions and analyzed with the chi-square method. In all analyses, a P-value of <0.05 (two tailed) was considered statistically significant
    Detailed Description
    A parallel, randomized, double-blind, active controlled, single center clinical trial was designed to compare the efficacy of two antibiotic therapies with 24-month follow-up. The study protocol was approved by the ethical committee of the Universitary Center of Health Sciences of University of Guadalajara and conducted according to Good Clinical Practice and the principles of the Declaration of Helsinki. All patients provided written informed consent before the initiation of study procedures. A total of 5 non-study subjects with chronic periodontitis were recruited and used for the calibration exercise. Two designated examiners measured full-mouth probing pockets depths (PPD) for all 5 subjects. On the same day (with a minimum of 15 min separation), the examiner repeated the examination. Upon completion of all measurements, the intra-examiner repeatability for PPD measurement was assessed. The examiner was judged to be reproducible after fulfilling the pre-determined success criteria (the percentage of agreement within 2 mm between repeated measurements had to be at least 70 %). The examiner showed 78.3 % reproducibility. The sample size was calculated with a 95% confidence level and statistical power of 80 %. A standard deviation of 1.0 mm with an expected difference of 1.0 mm probing pocket depth reduction between treatments. This resulted in a total of 14 patients per arm, however this sample was increased 20% (21 patients per group) to compensate for possible dropouts. Patient population Criteria for selection Patients of both sexes (aged >18 to 70 years) with a diagnosis of chronic periodontitis according to the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions and a history of type 2 diabetes with a HbA1C < 8 % and a fasting plasma glucose (FPG) < 180 mg/dL. Patients with aggressive periodontitis, pregnant or lactating females, required antibiotic pre-medication for the performance of periodontal examination and treatment or received antibiotic treatment in the previous 3 months were excluded. A history of anti-inflammatory therapy within preceding six months or that had received a course of periodontal treatment within the last 6 months, allergies to penicillin, metronidazole or clindamycin, and were not able to provide consent to participate in the study were also criteria for exclusion. Intervention Subjects were randomly allocated 1:1 to receive 500 mg amoxicillin + 250 mg metronidazole or 300 mg clindamycin + placebo using a computer that generated a list of random numbers. Subjects were instructed to take the treatment three times a day for 7 days in both groups. Assessments During these sessions, a case presentation was given to each subject related to the specific features of his/her disease, as well as a supra- and sub-gingival mechanical debridement was performed. A complete periodontal examination was performed, including a full medical and dental history, an intra-oral examination and a full-mouth periodontal probing. A radiographic examination was undertaken using either periapical x-rays or a ortopantomography. Clinical parameters Clinical parameters were assessed using a North Caroline Periodontal Probe by the calibrated examiner at six sites. Full-mouth plaque scores were recorded by assigning a binary score to each surface (1 for plaque present, 0 for absent) and by calculating the percentage of total tooth surfaces that revealed the presence of plaque detected by the use of tablet. Similarly, a full-mouth percentage bleeding score was calculated after assessing dichotomously the presence of bleeding on probing from the bottom of the pocket when probing with a manual probe with a force of 0.3n. Full-mouth PPD and recession of the gingival margin were recorded at the same time with measurements rounded to the nearest millimeter. Non-surgical periodontal therapy Periodontal therapy was initiated within 1 month of the baseline screening examination. A standard cycle of periodontal therapy consisting of oral hygiene instructions, supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planning) was performed by two experienced therapists. Local anesthesia was used as necessary. Patients relied on standard oral hygiene methods as instructed at the commencement of the study. Post-treatment controls The objectives of the post-treatment appointments were to control and reinforce the oral hygiene habits of each subject, to monitor the early healing events and to report any adverse events or additional medications taken. In addition, the 1-week post-treatment visit served as a compliance control, as subjects were asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the study subjects was documented. Re-assessment examinations Reassessment visits occurred within a month and a half of the completion of the pharmacological treatment. During these appointments, the examiner recorded any changes in the medical history and repeated clinical periodontal parameters recorded at the basal visit. Statistical analysis Age, FPG, HbA1C, tooth, and sounding depth were presented in means and standard deviation. The intra-group differences were calculated with Wilcoxon rank test. The inter-group differences were calculated with Mann-Whitney test. Sex, bacterial plaque, and bleed to the sounding were summarized using proportions and analyzed with the chi-square method. In all analyses, a P-value of <0.05 (two tailed) was considered statistically significant. All statistical analyses were conducted using SPSS software (IBM Corporation, Armonk, NY, USA) version 21.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Periodontal Pocket, Diabetes Mellitus
    Keywords
    periodontitis, diabetes mellitus, systemic antimicrobials

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AMX-MET
    Arm Type
    Active Comparator
    Arm Description
    AMX-MET Amoxicillin 500 mg + Metronidazole 250 mg. Capsules. 1 capsule tid during 7 days.
    Arm Title
    Clindamycin
    Arm Type
    Experimental
    Arm Description
    Clindamycin Clindamycin 300 mg + placebo. Capsules. 1 capsule tid during 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Amoxicillin 500 mg / Metronidazole 250 mg
    Intervention Description
    Subjects were instructed to take a capsule three times a day for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Clindamycin 300 mg
    Intervention Description
    Subjects were instructed to take a capsule three times a day for 7 days
    Primary Outcome Measure Information:
    Title
    Probing Depth
    Description
    The size of the periodontal pocket
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Sites With Plaques
    Description
    0: no plaque separate flecks of plaque at the cervical margin of the tooth a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth a continuous band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth plaque covering at least one-third but less than two-thirds of the crown of the tooth plaque covering two-thirds or more of the crown of the tooth. A higher scores mean a worse outcome
    Time Frame
    7 days
    Title
    Sites With Bleeding on Probing
    Description
    Refers to bleeding on probing 0: absence of inflammation mild inflammation; a slight change in color, little change in the texture of any portion of but not the entire marginal or papillary gingival unit mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4; severe inflammation; marked redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
    Time Frame
    7 days
    Title
    Total Count of All Teeth Lost Across All Participants
    Description
    The total count of all teeth lost in all participants.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients of both sexes Age >18 to 70 years Diagnosis of chronic periodontitis according to the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions History of type 2 diabetes HbA1C < 8 % Fasting plasma glucose (FPG) < 180 mg/dL. Exclusion Criteria: Aggressive periodontitis Pregnant or lactating females, Required antibiotic pre-medication for the performance of periodontal examination and treatment or received antibiotic treatment in the previous 3 months were excluded. A history of anti-inflammatory therapy within preceding six months Had received a course of periodontal treatment within the last 6 months, Allergies to penicillin, metronidazole or clindamycin, Not able to provide consent to participate in the study

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Amoxicillin-metronidazole Compared to Clindamycin in Patients With Periodontitis and Diabetes

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