Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment

NCT03933501 | Completed Phase 4

• 1 other identifier: 06/0024
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized Aggressive Periodontitis (GAgP).

Conditions

Generalized Aggressive Periodontitis

Keywords

Aggressive periodontitis; anti-infective agents; debridement; randomized clinical trial; ultrasonic

Outcome Measures

Primary Outcomes (1)

• Change of the baseline relative clinical attachment level at 6 months

  distance from the bottom of the pocket to the stent margin.

  Baseline, 3 months and 6 months

Secondary Outcomes (3)

• Change of the baseline probing depth at 6 months

  Baseline, 3 months and 6 months

• Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months

  Baseline, 3 months and 6 months

• Change in the microbial composition at 6 months

  Baseline, 3 months and 6 months

Study Arms (4)

FMUD + AM

EXPERIMENTAL

One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.

Drug: amoxicillin and metronidazole

FMUD

PLACEBO COMPARATOR

One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.

Drug: Placebos

SRP + AM

EXPERIMENTAL

Four sessions (1/week) of scaling and root planning, plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the last session of treatment and taken every 8 hours for 7 days.

Drug: amoxicillin and metronidazole

SRP

PLACEBO COMPARATOR

Four sessions (1/week) of scaling and root planning, plus two distinct placebo pills prescribed on the last session of treatment and taken every 8 hours for 7 days.

Drug: Placebos

Interventions

amoxicillin and metronidazole DRUG

375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.

FMUD + AM; SRP + AM

Placebos DRUG

Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.

FMUD; SRP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of GAgP;
• presence of 20 teeth;
• presence of teeth presenting PD\>5 mm with bleeding on probing (BOP) and 2 teeth with PD\>7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them);
• good general health;
• \<35 years of age.

You may not qualify if:

• were pregnant or lactating;
• were suffering from any other systemic diseases (e.g., cardiovascular, diabetes);
• received antimicrobials in the previous 3 months;
• were taking long-term anti-inflammatory drugs;
• received a course of periodontal treatment within the last 6 months;
• smoked

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Related Publications (1)

• Taiete T, Monteiro MF, Casati MZ, do Vale HF, Ambosano GMB, Nociti FH, Sallum EA, Casarin RCV. Local IL-10 level as a predictive factor in generalized aggressive periodontitis treatment response. Scand J Immunol. 2019 Dec;90(6):e12816. doi: 10.1111/sji.12816. Epub 2019 Oct 3.

  PMID: 31448837 DERIVED

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Amoxicillin; Metronidazole

Condition Hierarchy (Ancestors)

Periodontitis; 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; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at Piracicaba Dental School

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: January 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05