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Amoxicillin Plus Metronidazole in Periodontal Maintenance

Primary Purpose

Periodontitis, Periodontal Pocket

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams
placebo
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring amoxicillin, dental scaling, metronidazole, periodontal maintenance, periodontitis, root planing

Eligibility Criteria

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

Inclusion Criteria: individuals under a PMT program monitored over ~13 years of consecutive recall visits (from August 2009 to May 2023). individuals reclassified as stage III and IV periodontitis not having presented the following clinical endpoint in two consecutive PMT visits - presence of ≤4 sites with PD ≥5 mm non-diabetics non-smokers no antibiotic use for any purpose within 3 months prior to entering the study Exclusion Criteria: pregnant or lactating women smokers presence of systemic diseases that could affect the progression of periodontitis long-term administration of anti-inflammatory drugs, need for antibiotic premedication for routine dental therapy and allergy to metronidazole or amoxicillin

Sites / Locations

  • Federal University of Minas Gerais, Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control

antibiotics

Arm Description

1) scaling and root planing (SRP) plus systemic administration of placebo (n=25)

2) scaling and root planing (SRP) plus systemic administration of amoxicillin and metronidazole (n=25).

Outcomes

Primary Outcome Measures

whole-mouth periodontal pocket depth improvement
mean pocket depth (PD) in millimeters
changes in percentage of deep periodontal pocket
proportion of sites with PD ≥5 millimeters

Secondary Outcome Measures

total bacterial load in sub gingival samples
mean total bacterial load
levels of target species in sub gingival samples
mean levels of periodontal pathogens

Full Information

First Posted
June 17, 2023
Last Updated
August 29, 2023
Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT05934227
Brief Title
Amoxicillin Plus Metronidazole in Periodontal Maintenance
Official Title
Long-term Effects of Sub Gingival Debridement Associated With Antibiotics in Individual Undergoing Maintenance Periodontal Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

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
Gum disease require a lifetime supportive periodontal care aiming at preventing additional inflammation and bone resorption. During this phase it is also relevant to keep germs under acceptable levels through proper daily hygiene although patient's cooperation tends to decrease over time. There are conflicting opinions regarding combination of dental scaling with antibiotics. This is why the present study was designed to evaluate the clinical and microbiological effects of combined therapy 1 year following supportive periodontal care. Fifty patients who voluntarily decide to participate will receive dental scaling associated with two different antibiotics or placebo capsules. Paper points will be used to collect dental plaque samples and levels of bacteria will be determined. Dental specialists will also perform clinical examinations. Patients would be available for 4 dental appointments: prior to and 3, 6 and 12 months after dental scaling.
Detailed Description
The benefits of amoxicillin (AMX) plus metronidazole (MTZ) adjunctive to scaling and root planing (SRP) require further investigation, particularly in individuals with a high occurrence of recurrent periodontal pockets under periodontal maintenance therapy (PMT). The aim of the study was to evaluate the clinical and microbiological outcomes of systemic AMX+MTZ adjunctive to SRP in patients with recurring sites [probing depth (PD) ≥5 mm) under PMT, after 1 year of follow-up, compared to SRP alone. Methods: A randomized controlled clinical trial will be conducted with 50 individuals in a PMT program, which will be randomly allocate in two groups: control group (SRP and placebo; n=24) and test group (SRP and systemic MTZ+AMX; n=23). Participants of the present study will be selected from an open cohort study comprising individuals under a PMT program, who were monitored over 12 years of consecutive recall visits (from August 2009 to April 2023). Periodontal clinical parameters and subgingival biofilm samples will be collected by trained and calibrated examiners at baseline (T1), 3 (T2), 6 (T3) and 12 (T4) months after treatment. Microbiological analyses will be performed at T1, T2 and T4 by real-time quantitative polymerase chain reaction. The percentage of residual pockets will be listed. Additionally, an overall mean PD value will be calculated for the treated sites initially measuring ≥ 5mm and clinical attachment loss (CAL) ≥ 3mm. Statistical testing for normality with respect to the distribution of study outcomes (clinical parameters) will be performed using the Kolmogorov-Smirnov test. Parametric and non-parametric tests (Chi-squared, Wilcoxon and Friedman tests) will be performed when appropriate. Spearman's correlation (r) will be used to evaluate the relationship between bacterial counts and periodontal condition between groups and evaluation times. All analyses will be performed using statistical software Statistical Package for the Social Sciences (SPSS) (p < 0.05).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Periodontal Pocket
Keywords
amoxicillin, dental scaling, metronidazole, periodontal maintenance, periodontitis, root planing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After clinical examination, participants will be randomly allocated into two treatment groups: 1) control group (SRP) - systemic administration of placebo after SRP (n = 25); 2) test group (SRP+AMX+MTZ) - systemic administration of AMX+MTZ after SRP (n=25).
Masking
ParticipantCare ProviderInvestigator
Masking Description
A random sequence will be generated (Excel, Microsoft Office 365) and participants will be allocated in the groups according to sequential numbered opaque envelopes. Each envelope containing one of the two treatments will be open only at the time of the periodontal procedure by the operator. Participants, as well as the researcher that evaluated treatment clinical outcomes won't know which group they were assigned. It will be ensure that the patient, the main researcher, the operator, the examiner and the statistician will be unaware of study groups.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
1) scaling and root planing (SRP) plus systemic administration of placebo (n=25)
Arm Title
antibiotics
Arm Type
Experimental
Arm Description
2) scaling and root planing (SRP) plus systemic administration of amoxicillin and metronidazole (n=25).
Intervention Type
Drug
Intervention Name(s)
Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams
Other Intervention Name(s)
Amoxicillin Trihydrate, Amoxil
Intervention Description
supra and subgingival scaling and root planing (SRP) using manual and ultrasonic instruments in all residual pockets under anesthesia, performed within 2 consecutive days; systemic use of amoxicillin (500 milligrams) + metronidazole (400 milligrams) three times a day for 7 days after SRP
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
supra and subgingival scaling and root planing (SRP) using manual and ultrasonic instruments in all residual pockets under anesthesia, performed within 2 consecutive days; systemic use of placebo containing corn starch capsules three times a day for 7 days after SRP
Primary Outcome Measure Information:
Title
whole-mouth periodontal pocket depth improvement
Description
mean pocket depth (PD) in millimeters
Time Frame
baseline and 12 months
Title
changes in percentage of deep periodontal pocket
Description
proportion of sites with PD ≥5 millimeters
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
total bacterial load in sub gingival samples
Description
mean total bacterial load
Time Frame
baseline and 3 months
Title
levels of target species in sub gingival samples
Description
mean levels of periodontal pathogens
Time Frame
baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: individuals under a PMT program monitored over ~13 years of consecutive recall visits (from August 2009 to May 2023). individuals reclassified as stage III and IV periodontitis not having presented the following clinical endpoint in two consecutive PMT visits - presence of ≤4 sites with PD ≥5 mm non-diabetics non-smokers no antibiotic use for any purpose within 3 months prior to entering the study Exclusion Criteria: pregnant or lactating women smokers presence of systemic diseases that could affect the progression of periodontitis long-term administration of anti-inflammatory drugs, need for antibiotic premedication for routine dental therapy and allergy to metronidazole or amoxicillin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando O Costa, PhD
Organizational Affiliation
Titular Professor in periodontics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais, Dental School
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
31270-901
Country
Brazil

12. IPD Sharing Statement

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Amoxicillin Plus Metronidazole in Periodontal Maintenance

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