NCT02215460

Brief Summary

Periodontitis is a form of gum disease that affects many people in the world. Its traditional protocol of treatment includes oral hygiene instruction and dental scaling to remove debris, dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option also usually cheaper. In this last one, all above described procedures are performed within 24 hours. However, up to now comparative effectiveness between these both types of treatment is not well understood. For, example it is not clear if patients treated in the shorter-time experienced more pain. Therefore, the present study used several parameters to clarify whether beneficial differences between these therapeutic protocols exist or not. In addition, aspects that could help clinicians' and patient's decisions such as experience of pain and anxiety related to dental treatment were also investigated. After receiving verbal and written explanations and signed the informed consent form 150 individuals (n=15/group) having the most common type of periodontitis in adults were randomly allocated to be treated in 4 weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were performed alone or in conjunction with antimicrobial agents: a mouth rinse containing chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral debris and malodor; quantification of bacteria in plaque samples collected with paper points from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect information about oral condition, daily activities, pain and anxiety related to dental treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2012

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

April 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1.9 years

First QC Date

August 8, 2014

Last Update Submit

August 11, 2014

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Improvements in pocket depth and clinical attachment level measurements

    Primary outcomes of effectiveness were improvements of the following clinical parameters: periodontal pocket depth (mm) and clinical attachment level (mm) from baseline to 6 months.

    Changes in pocket depth and clinical attachment level measurements from baseline to 6 months

Secondary Outcomes (4)

  • Improvements in plaque index and gingival index

    Changes from baseline to 3 months

  • Maintenance of pocket depth and clinical attachment level measurements

    Changes in pocket depth and clinical attachment level from 6 months to 9 months

  • Changes in total bacterial load and levels of selected pathogens

    3 months

  • Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines

    3 months

Other Outcomes (6)

  • Impact of periodontal treatment on quality of life

    6 and 9 months

  • Impact of periodontal disease on quality of life

    Baseline

  • Dental Anxiety experience

    Baseline

  • +3 more other outcomes

Study Arms (10)

Full-mouth scaling (FMS)

EXPERIMENTAL
Procedure: FMS full-mouth scaling

FMS chlorhexidine rinse

EXPERIMENTAL
Procedure: FMS full-mouth scalingDrug: FMS chlorhexidine rinse

FMS azithromycin tablets

EXPERIMENTAL
Procedure: FMS full-mouth scalingDrug: FMS azithromycin tablets

FMS placebo rinse

PLACEBO COMPARATOR
Procedure: FMS full-mouth scalingDrug: FMS placebo rinse

Quadrant scaling (QS)

EXPERIMENTAL
Procedure: QS quadrant scaling

QS chlorhexidine rinse

EXPERIMENTAL
Procedure: QS quadrant scalingDrug: QS chlorhexidine rinse

QS azithromycin tablets

EXPERIMENTAL
Procedure: QS quadrant scalingDrug: QS azithromycin tablets

QS placebo tablets

PLACEBO COMPARATOR
Procedure: QS quadrant scalingDrug: QS placebo tablets

FMS placebo tablets

PLACEBO COMPARATOR
Procedure: FMS full-mouth scalingDrug: FMS placebo tablets

QS placebo rinse

PLACEBO COMPARATOR
Procedure: QS quadrant scalingDrug: QS placebo rinse

Interventions

FMS full-mouth scalingPROCEDURE

Participants received oral hygiene instructions and full-mouth scaling within 24 hours. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

FMS azithromycin tabletsFMS chlorhexidine rinseFMS placebo rinseFMS placebo tabletsFull-mouth scaling (FMS)
QS quadrant scalingPROCEDURE

Participants received oral hygiene instructions and quadrant scaling in 4 weekly sections. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

QS azithromycin tabletsQS chlorhexidine rinseQS placebo rinseQS placebo tabletsQuadrant scaling (QS)
FMS chlorhexidine rinseDRUG

Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

FMS chlorhexidine rinse
FMS placebo rinseDRUG

Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of placebo mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

FMS placebo rinse
FMS azithromycin tabletsDRUG

Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

FMS azithromycin tablets
FMS placebo tabletsDRUG

Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

FMS placebo tablets
QS azithromycin tabletsDRUG

Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

QS azithromycin tablets
QS placebo tabletsDRUG

Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

QS placebo tablets
QS chlorhexidine rinseDRUG

Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

QS chlorhexidine rinse
QS placebo rinseDRUG

Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% placebo mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.

QS placebo rinse

Eligibility Criteria

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

You may qualify if:

  • mild to moderate chronic periodontitis;
  • at least 20 natural teeth;
  • good general health

You may not qualify if:

  • systemic diseases or other conditions that could influence the periodontal status;
  • events of high blood pressure or diagnosed hypertension;
  • alcohol abuse;
  • orthodontic devices;
  • extended prosthetic fixed devices, removable partial dentures or overhanging restorations;
  • pregnancy or breast-feeding;
  • history of sensitivity or suspected allergies following the use of oral hygiene products and/or the test antibiotic;
  • the need for antibiotic prophylaxis;
  • antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;
  • regular use of chemotherapeutic antiplaque/antigingivitis products;
  • any furcation lesions;
  • periodontal treatment performed within six months prior to study initiation;
  • unwillingness to return for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus of periodontal research of University of Taubate

Taubaté, São Paulo, 12020330, Brazil

Location

Related Publications (3)

  • Cortelli JR, CASTRO MVM; BALEJO RDP, ALENCAR CO, GARGIONI AC, CORTELLI SC, COSTA FO. Clinical and microbiological evaluation of one-stage full-mouth disinfection: a short-term study. Revista de Odontologia da UNESP (Online), v. 42, p. 298-303, 2013. DOI: doi.org/10.1590/S1807-25772013000400010.

    RESULT

  • CORTELLI JR. et al. Clinical/Microbiological Comparative Effects between Full-mouth and Quadrant Debridement plus Chlorhexidine. In: IADR, 2013, SEATTLE. IADR, 2013.

    RESULT

  • CORTELLI JR, COSTA FO, ALENCAR CO, CASTRO MVM, GARGIONI AC, AQUINO DR, CORTELLI SC. CLINICAL EFFECTS OF FULL MOUTH OR QUADRANT DEBRIDEMENT WITH CHLOREXIDINA OR AZITROMYCIN. In: IADR-ASIA PACIFIC REGION, 2013, BANGKOK. IADR-APR, 2013. v. 1. p. 158-158.

    RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 13, 2014

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

BR(1)