Clinical trial NCT05934227: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Periodontal Pocket
Keywords: amoxicillin
dental scaling
metronidazole
periodontal maintenance
periodontitis
root planing
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2023-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: whole-mouth periodontal pocket depth improvement
timeFrame: baseline and 12 months
measure: changes in percentage of deep periodontal pocket
timeFrame: baseline and 12 months
Secondary outcomes:
measure: total bacterial load in sub gingival samples
timeFrame: baseline and 3 months
measure: levels of target species in sub gingival samples
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais, Dental School
state: Minas Gerais
Study officials:
affiliation: Titular Professor in periodontics
name: Fernando O Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: