NCT01837199

Brief Summary

Randomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX) and metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and microbiological outcomes of scaling and root planing (SRP) in non-smokers and smokers with ChP. However, the effects of this antibiotic protocol have not been directly compared in non-smokers and smokers. Therefore, the aim of this study will be to compare the clinical and microbiological effects of the adjunctive use of MTZ+AMX to SRP in smokers and non-smokers subjects with chronic periodontitis (ChP). It was hypothesized that non-smokers would benefit better from this combination of therapies than the smokers.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

April 15, 2013

Last Update Submit

April 17, 2013

Conditions

Chronic PeriodontitisSmoking

Keywords

Periodontal diseaseScaling and root planingMetronidazoleAmoxicillinGeneralized chronic periodontitisPeriodontal treatment

Outcome Measures

Primary Outcomes (1)

  • Mean clinical attachment level change post- scaling and root planing in sites with initial probing depth ≥ 7 mm

    At 3, 6 and 12 months post-therapy.

Secondary Outcomes (8)

  • Number of subjects with low, moderate and high risk for disease progression.

    At 3, 6 and 12 months post-therapy

  • Mean full-mouth clinical attachment level.

    Baseline and at 3, 6 and 12 months post-therapy

  • Mean full-mouth probing depth.

    Baseline and at 3, 6 and 12 months post-therapy.

  • Mean clinical attachment level change post-scaling and root planing in sites with initial probing depth between 4-6 mm

    At 3, 6 and 12 months post-therapy

  • Mean probing depth reduction post-scaling and root planing in sites with initial probing depth between 4-6 mm

    At 3, 6 and 12 months post-therapy.

  • +3 more secondary outcomes

Study Arms (2)

Smoking

EXPERIMENTAL

Metronidazole plus Amoxicillin

Drug: Metronidazole plus Amoxicillin

Non-Smoking

EXPERIMENTAL

Metronidazole plus Amoxicillin

Drug: Metronidazole plus Amoxicillin

Interventions

Metronidazole plus AmoxicillinDRUG

All subjects will receive scaling and root planing combined with systemic metronidazole (400 mg) and amoxicillin (500 mg). Both antibiotics were administered T.I.D. for 14 days.

Also known as: Metronidazole, Amoxicillin, Scaling and root planing
Non-SmokingSmoking

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic periodontitis (AAP 1999);
  • ≥35 years of age;
  • Presence of at least 15 teeth;
  • Minimum of 6 teeth with at least one site each with PD and clinical attachment level (CAL) ≥5 mm;
  • At least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).
  • Smokers: had smoked at least 10 cigarettes per day for a minimum of 5 years;
  • Non-smokers: had never smoked.

You may not qualify if:

  • Previous subgingival periodontal therapy;
  • Pregnancy;
  • Nursing;
  • Systemic diseases that could affect the progression of periodontal disease (e.g. diabetes, osteoporosis);
  • Long-term administration of anti - inflammatory medications;
  • Need for antibiotic pre-medication for routine dental therapy;
  • Continuous use of mouthrinses containing antimicrobials;
  • Antibiotic therapy in the previous 6 months
  • Allergy to MTZ or AMX.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guarulhos

Guarulhos, São Paulo/ SP, 07023-070, Brazil

Location

MeSH Terms

Conditions

Chronic PeriodontitisSmokingPeriodontal Diseases

Interventions

MetronidazoleAmoxicillinTooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Marcelo Faveri, DDS, PhD.

    University of Guarulhos

    PRINCIPAL INVESTIGATOR

  • Magda Feres, DDS, PhD.

    University of Guarulhos

    PRINCIPAL INVESTIGATOR

  • Luciene C Figueiredo, DDS, PhD.

    University of Guarulhos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD.

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 23, 2013

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

BR(1)