Amoxicillin Plus Metronidazole in Periodontal Maintenance

NCT05934227 | Completed DMC

• 1 other identifier: 5.957.583
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Periodontal Pocket

Keywords

amoxicillin; dental scaling; metronidazole; periodontal maintenance; periodontitis; root planing

Outcome Measures

Primary Outcomes (2)

• whole-mouth periodontal pocket depth improvement

  mean pocket depth (PD) in millimeters

  baseline and 12 months

• changes in percentage of deep periodontal pocket

  proportion of sites with PD ≥5 millimeters

  baseline and 12 months

Secondary Outcomes (2)

• total bacterial load in sub gingival samples

  baseline and 3 months

• levels of target species in sub gingival samples

  baseline and 3 months

Study Arms (2)

control

PLACEBO COMPARATOR

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

Other: placebo

antibiotics

EXPERIMENTAL

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

Drug: Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams

Interventions

Amoxicillin 500 milligrams capsules plus metronidazole 400 milligrams DRUG

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

Also known as: Amoxicillin Trihydrate, Amoxil

antibiotics

placebo OTHER

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

control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Federal University of Minas Gerais, Dental School

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fernando O Costa, PhD

  Titular Professor in periodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: July 6, 2023
• Study Start: July 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

BR (1)