NCT02126267

Brief Summary

Evaluate and compare the effectiveness in a clinical and microbial perspective one stage full-mouth disinfection technique in relation to scaling and root planing per quadrant associated with chlorhexidine or azithromycin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

April 21, 2014

Last Update Submit

April 27, 2014

Conditions

Periodontal DiseaseChronic Periodontitis

Keywords

periodontal diseasetherapyanti-bacterial agentsRandomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

  • Change in clinical attachment

    In this parameter we will evaluate the distance from the cement-enamel junction to the bottom of the periodontal pocket or gingival sulcus. This measurement is made with a periodontal probe graduated in millimeters

    Baseline and 180 days after treatment

Secondary Outcomes (1)

  • Change in probing depth

    Baseline and 180 days after treatment

Study Arms (6)

Full mouth disinfection - FMD

EXPERIMENTAL

n = 10: Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days

Procedure: Full mouth disinfection

FMD + chlorhexidine (FMD-CX)

EXPERIMENTAL

n = 15: Same as FMD with the inclusion of chlorhexidine in office (application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)). In addition, use was made of homemade CX 0.2% for 60 days after the scaling in a single phase.

Procedure: Full mouth disinfectionDrug: Chlorhexidine gel and gluconateDrug: Chlorhexidine gluconate solution

FMD + azithromycin (FMD-AZ)

EXPERIMENTAL

n = 15: Same as with the FMD include the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the scaling.

Procedure: Full mouth disinfectionDrug: Azithromycin

Scaling and root planing (SRP)

EXPERIMENTAL

(n = 13): scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;

Procedure: Scaling and root planing

SRP + azithromycin (SRP-AZ)

EXPERIMENTAL

n = 11: Same as scaling and root planing group (SRP) with inclusion of the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the last scaling hemi-arch;

Procedure: Scaling and root planingDrug: Azithromycin

SRP + chlorhexidine (SRP-CX)

EXPERIMENTAL

n = 13 : Same as group scaling and root planing (SRP) with the inclusion of home use of CX 0.2% for 60 consecutive days after the end of the first session of scaling

Procedure: Scaling and root planingDrug: Chlorhexidine gluconate solution

Interventions

Scaling and root planingPROCEDURE

Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;

SRP + azithromycin (SRP-AZ)SRP + chlorhexidine (SRP-CX)Scaling and root planing (SRP)
Full mouth disinfectionPROCEDURE

Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days

FMD + azithromycin (FMD-AZ)FMD + chlorhexidine (FMD-CX)Full mouth disinfection - FMD
Chlorhexidine gel and gluconateDRUG

application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)

FMD + chlorhexidine (FMD-CX)
Chlorhexidine gluconate solutionDRUG

Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.

FMD + chlorhexidine (FMD-CX)SRP + chlorhexidine (SRP-CX)
AzithromycinDRUG

Azithromycin (500 mg) once daily for 3 consecutive days.

FMD + azithromycin (FMD-AZ)SRP + azithromycin (SRP-AZ)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of slight-moderate chronic periodontitis

You may not qualify if:

  • Those who were making regular use of antibiotics or anti-inflammatory drugs or had done up to three months before the beginning of the study;
  • those who were making regular use (twice a day) of oral rinses with chlorhexidine or essential oils or have made regular use within three months prior to study entry;
  • individuals with a history of sensitivity to chlorhexidine or azithromycin;
  • subjects undergoing periodontal therapy include dental scaling procedures in the 12 months preceding the start of the study;
  • subjects with impaired bifurcation or trifurcation class III;
  • who required antibiotic prophylaxis for conducting clinical periodontal examination
  • subjects with removable partial dentures and removable or fixed orthodontic appliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Campideli Fonseca

Lavras, Minas Gerais, 37200000, Brazil

Location

Related Publications (1)

  • Emingil G, Han B, Ozdemir G, Tervahartiala T, Vural C, Atilla G, Baylas H, Sorsa T. Effect of azithromycin, as an adjunct to nonsurgical periodontal treatment, on microbiological parameters and gingival crevicular fluid biomarkers in generalized aggressive periodontitis. J Periodontal Res. 2012 Dec;47(6):729-39. doi: 10.1111/j.1600-0765.2012.01488.x. Epub 2012 May 9.

    PMID: 22571226RESULT

MeSH Terms

Conditions

Periodontal DiseasesChronic Periodontitis

Interventions

Tooth ExfoliationRoot Planinggluconic acidAzithromycin

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPeriodontitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive DentistryErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Douglas C Fonseca, Ms

    Universitary Center of Lavras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of Science

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 29, 2014

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

April 29, 2014

Record last verified: 2014-04

Locations

BR(1)