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Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
FMS full-mouth scaling
QS quadrant scaling
FMS chlorhexidine rinse
FMS placebo rinse
FMS azithromycin tablets
FMS placebo tablets
QS azithromycin tablets
QS placebo tablets
QS chlorhexidine rinse
QS placebo rinse
Sponsored by
University of Taubate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Nucleus of periodontal research of University of Taubate

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Full-mouth scaling (FMS)

FMS chlorhexidine rinse

FMS azithromycin tablets

FMS placebo rinse

Quadrant scaling (QS)

QS chlorhexidine rinse

QS azithromycin tablets

QS placebo tablets

FMS placebo tablets

QS placebo rinse

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improvements in plaque index and gingival index
Improvements in plaque index (scores) and gingival index (scores) when baseline data was compared to 3 months data.
Maintenance of pocket depth and clinical attachment level measurements
Pocket depth (mm) and clinical attachment level (mm) values observed at 6 were compared to those observed at 9 months.
Changes in total bacterial load and levels of selected pathogens
Reductions in total bacterial load and levels of selected pathogens were determined by real time PCR (polymerase chain reaction) in samples from periodontal pockets and dorsal tongue. Values between baseline and 3 months were compared.
Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines
Possible reductions in gingival crevicular fluid volume and in concentrations of tumor necrosis factor alfa (TNFα) and interleukin 1 beta (IL-1β) were measured by comparing values between baseline and 3 months.

Full Information

First Posted
August 8, 2014
Last Updated
August 11, 2014
Sponsor
University of Taubate
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02215460
Brief Title
Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours
Official Title
Effectiveness of Two Non-surgical Periodontal Treatment Protocols: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Taubate
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full-mouth scaling (FMS)
Arm Type
Experimental
Arm Title
FMS chlorhexidine rinse
Arm Type
Experimental
Arm Title
FMS azithromycin tablets
Arm Type
Experimental
Arm Title
FMS placebo rinse
Arm Type
Placebo Comparator
Arm Title
Quadrant scaling (QS)
Arm Type
Experimental
Arm Title
QS chlorhexidine rinse
Arm Type
Experimental
Arm Title
QS azithromycin tablets
Arm Type
Experimental
Arm Title
QS placebo tablets
Arm Type
Placebo Comparator
Arm Title
FMS placebo tablets
Arm Type
Placebo Comparator
Arm Title
QS placebo rinse
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
FMS full-mouth scaling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
QS quadrant scaling
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
FMS chlorhexidine rinse
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
FMS placebo rinse
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
FMS azithromycin tablets
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
FMS placebo tablets
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
QS azithromycin tablets
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
QS placebo tablets
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
QS chlorhexidine rinse
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
QS placebo rinse
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvements in pocket depth and clinical attachment level measurements
Description
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.
Time Frame
Changes in pocket depth and clinical attachment level measurements from baseline to 6 months
Secondary Outcome Measure Information:
Title
Improvements in plaque index and gingival index
Description
Improvements in plaque index (scores) and gingival index (scores) when baseline data was compared to 3 months data.
Time Frame
Changes from baseline to 3 months
Title
Maintenance of pocket depth and clinical attachment level measurements
Description
Pocket depth (mm) and clinical attachment level (mm) values observed at 6 were compared to those observed at 9 months.
Time Frame
Changes in pocket depth and clinical attachment level from 6 months to 9 months
Title
Changes in total bacterial load and levels of selected pathogens
Description
Reductions in total bacterial load and levels of selected pathogens were determined by real time PCR (polymerase chain reaction) in samples from periodontal pockets and dorsal tongue. Values between baseline and 3 months were compared.
Time Frame
3 months
Title
Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines
Description
Possible reductions in gingival crevicular fluid volume and in concentrations of tumor necrosis factor alfa (TNFα) and interleukin 1 beta (IL-1β) were measured by comparing values between baseline and 3 months.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Impact of periodontal treatment on quality of life
Description
The expected positive effect of periodontal treatment on quality of life (score) was measured by comparing baseline data and data collected at 6 and 9 months after therapy
Time Frame
6 and 9 months
Title
Impact of periodontal disease on quality of life
Description
The expected negative effect of periodontal disease on quality of life (score) was measured by analyzing baseline data.
Time Frame
Baseline
Title
Dental Anxiety experience
Description
Dental Anxiety (score) was measured immediately before treatment.
Time Frame
Baseline
Title
Experience of pain
Description
Experience of pain (scale) due to type of scaling was evaluated immediately after treatment.
Time Frame
at the second day for full-mouth scaling groups; or at month for quadrant scaling groups.
Title
Changes in nitrite levels
Description
Changes in nitrite levels (mean values) in saliva was determined by comparing baseline and 6 months values.
Time Frame
6 months
Title
Improvements in organoleptic and volatile sulphur compounds measurements
Description
The expected positive impact of periodontal treatment on organoleptic (score) and volatile sulphur compounds (mean values) measurements were evaluated at 3 months.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mild to moderate chronic periodontitis; at least 20 natural teeth; good general health Exclusion Criteria: 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.
Facility Information:
Facility Name
Nucleus of periodontal research of University of Taubate
City
Taubate
State/Province
SP
ZIP/Postal Code
12020330
Country
Brazil

12. IPD Sharing Statement

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

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Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours

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