Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

NCT ID: NCT02839421

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-05-31

Brief Summary

The aim of the present study is to evaluate the clinical and microbiological efficacy of moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in treating generalized aggressive periodontitis. Forty five subjects will be randomly allocated to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable bacteria. The primary outcome variable to determine the superiority of one treatment over the others would be differences between groups for means CAL changes at 6 months post-treatment. Secondary outcome variables include differences between therapies for the mean changes in the mean levels of PD and the proportion of BOP.

Conditions

Aggressive Periodontitis

Study Design

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

Study Groups

Scaling and Root Planing plus moxifloxacin

The interventions are Scaling and Root Planing (SRP) combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days.The experimental treatment group consist of SRP combined with systemically administered MOX at the dosage of 400 mg once daily for 7 days.One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The adjunctive agent will start at the SRP visit. Subjects in the MOX group will be extensively informed about the intake of the prescribed medication.

Group Type: EXPERIMENTAL

Scaling and Root Planing combined with moxifloxacin

Intervention Type: DRUG

Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days

Scaling and Root Planing plus amox-metro

The active comparator is Scaling and Root Planing (SRP) combined with systemically administered Amoxicillin (amox) + Metronidazole (metro) 500 mg tid each one for 7 days. The active comparator group consist of SRP combined with systemically administered Amoxicillin (amox) + Metronidazole (metro) 500 mg tid each one for 7 days.

One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The adjunctive agent will start at the SRP visit. Subjects in the amox-metro group will be extensively informed about the intake of the prescribed medication.

Group Type: ACTIVE_COMPARATOR

Scaling and Root Planing combined with moxifloxacin

Intervention Type: DRUG

Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days

Scaling and Root Planing plus placebo

Scaling and Root Planing (SRP) + placebo once daily for 7 days. The placebo comparator group consist of SRP combined with systemically administered placebo once daily for 7 days. One-stage full-mouth SRP under local anesthesia will be performed (using manual instruments and ultrasonic debridement) in approximately 2 h and half by the same experienced clinician.The endpoint of SRP will be a tactile smooth root surface. The placebo agent will start at the SRP visit. Subjects in the placebo group will be extensively informed about the intake of the prescribed medication.

Group Type: PLACEBO_COMPARATOR

Scaling and Root Planing combined with moxifloxacin

Intervention Type: DRUG

Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days

Interventions

Scaling and Root Planing combined with moxifloxacin

Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days

Intervention Type: DRUG

Other Intervention Names

periodontal scaling

Eligibility Criteria

Inclusion Criteria

• Subjects ≤30 years of age
• minimum of six permanent teeth, with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and a minimum of six teeth other than first molars and incisors with at least one site each with PD and CAL ≥5 mm.

Exclusion Criteria

• diabetes
• cardiovascular diseases
• immunological disorders or any other systemic disease that could alter the course of periodontal disease.
• Pregnant or nursing women
• smoking
• allergy to amoxicillin, metronidazole, fluoroquinolones or moxifloxacin
• consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months
• periodontal therapy during the last 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Facultad Nacional de Salud Publica

OTHER

Sponsor Role: lead

Responsible Party

Carlos Martin Ardila Medina

Titular Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry

Medellín, Antioquia, Colombia

Countries

Colombia

References

Hammami C, Nasri W. Antibiotics in the Treatment of Periodontitis: A Systematic Review of the Literature. Int J Dent. 2021 Nov 8;2021:6846074. doi: 10.1155/2021/6846074. eCollection 2021.

Reference Type: DERIVED

PMID: 34790237 (View on PubMed)

Other Identifiers

003

Identifier Type: -

Identifier Source: org_study_id