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

NCT ID: NCT03933501

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-01
• Study Completion Date: 2018-12-01

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).

Detailed Description

Forty eight GAgP patients were divided into 4 groups: the SRP group (n = 12), which received SRP plus placebo, and the SRP+AM group (n = 12), which received SRP and 375mg amoxicillin plus 250 mg metronidazole for 7 days, the FMUD group (n = 12), which received FMUD plus placebo, and the FMUD+AM group (n = 12), which received FMUD and 375mg amoxicillin plus 250 mg metronidazole for 7 days. The following clinical outcomes were tested: plaque and bleeding on probing indices, pocket probing depth (PD), relative gingival margin position (GMP), and relative clinical attachment level (CAL). The total amount of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and gingival crevicular fluid (GCF) concentration of interleukin (IL)-10 and IL-1b were also determined. All clinical, microbiological, and immunological parameters were assessed at baseline and at 3 and 6 months post-therapy. The ANOVA/Tukey test was used for statistical analysis (a = 5%).

Conditions

Generalized Aggressive Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

FMUD + AM

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.

Group Type: EXPERIMENTAL

amoxicillin and metronidazole

Intervention Type: DRUG

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

FMUD

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

SRP + AM

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.

Group Type: EXPERIMENTAL

amoxicillin and metronidazole

Intervention Type: DRUG

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

SRP

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

amoxicillin and metronidazole

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

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Renato Casarin

Professor at Piracicaba Dental School

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31448837 (View on PubMed)

Other Identifiers

06/0024

Identifier Type: -

Identifier Source: org_study_id