Amoxicillin Plus Metronidazole in Periodontal Maintenance

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05934227

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis Periodontal Pocket	Drug: Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams Other: placebo	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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:

Triple (Participant, Care Provider, Investigator)

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.

Primary Purpose:

Treatment

Official Title:

Long-term Effects of Sub Gingival Debridement Associated With Antibiotics in Individual Undergoing Maintenance Periodontal Therapy

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control 1) scaling and root planing (SRP) plus systemic administration of placebo (n=25)	Other: placebo 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
Experimental: antibiotics 2) scaling and root planing (SRP) plus systemic administration of amoxicillin and metronidazole (n=25).	Drug: Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams 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 Other Names: Amoxicillin Trihydrate Amoxil

Arm

Intervention/Treatment

Placebo Comparator: control

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

Other: placebo

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

Experimental: antibiotics

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

Drug: Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams

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

Other Names:

Amoxicillin Trihydrate

Amoxil

Outcome Measures

Primary Outcome Measures

whole-mouth periodontal pocket depth improvement [baseline and 12 months]
mean pocket depth (PD) in millimeters
changes in percentage of deep periodontal pocket [baseline and 12 months]
proportion of sites with PD ≥5 millimeters

Secondary Outcome Measures

total bacterial load in sub gingival samples [baseline and 3 months]
mean total bacterial load
levels of target species in sub gingival samples [baseline and 3 months]
mean levels of periodontal pathogens

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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