Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215460
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Taubate

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.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: FMS full-mouth scaling Procedure: QS quadrant scaling Drug: FMS chlorhexidine rinse Drug: FMS placebo rinse Drug: FMS azithromycin tablets Drug: FMS placebo tablets Drug: QS azithromycin tablets Drug: QS placebo tablets Drug: QS chlorhexidine rinse Drug: QS placebo rinse Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Two Non-surgical Periodontal Treatment Protocols: Randomized Controlled Clinical Trial
Study Start Date : April 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Full-mouth scaling (FMS) Procedure: FMS full-mouth scaling
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.

Experimental: FMS chlorhexidine rinse Procedure: FMS full-mouth scaling
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.

Drug: FMS chlorhexidine rinse
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.

Experimental: FMS azithromycin tablets Procedure: FMS full-mouth scaling
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.

Drug: FMS azithromycin tablets
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.

Placebo Comparator: FMS placebo rinse Procedure: FMS full-mouth scaling
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.

Drug: FMS placebo rinse
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.

Experimental: Quadrant scaling (QS) Procedure: QS quadrant scaling
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.

Experimental: QS chlorhexidine rinse Procedure: QS quadrant scaling
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.

Drug: QS chlorhexidine rinse
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.

Experimental: QS azithromycin tablets Procedure: QS quadrant scaling
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.

Drug: QS azithromycin tablets
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.

Placebo Comparator: QS placebo tablets Procedure: QS quadrant scaling
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.

Drug: QS placebo tablets
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.

Placebo Comparator: FMS placebo tablets Procedure: FMS full-mouth scaling
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.

Drug: FMS placebo tablets
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.

Placebo Comparator: QS placebo rinse Procedure: QS quadrant scaling
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.

Drug: QS placebo rinse
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 Measures :
  1. Improvements in pocket depth and clinical attachment level measurements [ Time Frame: Changes in pocket depth and clinical attachment level measurements from baseline to 6 months ]
    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 :
  1. Improvements in plaque index and gingival index [ Time Frame: Changes from baseline to 3 months ]
    Improvements in plaque index (scores) and gingival index (scores) when baseline data was compared to 3 months data.

  2. Maintenance of pocket depth and clinical attachment level measurements [ Time Frame: Changes in pocket depth and clinical attachment level from 6 months to 9 months ]
    Pocket depth (mm) and clinical attachment level (mm) values observed at 6 were compared to those observed at 9 months.

  3. Changes in total bacterial load and levels of selected pathogens [ Time Frame: 3 months ]
    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.

  4. Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines [ Time Frame: 3 months ]
    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.


Other Outcome Measures:
  1. Impact of periodontal treatment on quality of life [ Time Frame: 6 and 9 months ]
    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

  2. Impact of periodontal disease on quality of life [ Time Frame: Baseline ]
    The expected negative effect of periodontal disease on quality of life (score) was measured by analyzing baseline data.

  3. Dental Anxiety experience [ Time Frame: Baseline ]
    Dental Anxiety (score) was measured immediately before treatment.

  4. Experience of pain [ Time Frame: at the second day for full-mouth scaling groups; or at month for quadrant scaling groups. ]
    Experience of pain (scale) due to type of scaling was evaluated immediately after treatment.

  5. Changes in nitrite levels [ Time Frame: 6 months ]
    Changes in nitrite levels (mean values) in saliva was determined by comparing baseline and 6 months values.

  6. Improvements in organoleptic and volatile sulphur compounds measurements [ Time Frame: 3 months ]
    The expected positive impact of periodontal treatment on organoleptic (score) and volatile sulphur compounds (mean values) measurements were evaluated at 3 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215460


Locations
Layout table for location information
Brazil
Nucleus of periodontal research of University of Taubate
Taubate, SP, Brazil, 12020330
Sponsors and Collaborators
University of Taubate
Fundação de Amparo à Pesquisa do Estado de São Paulo

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

Layout table for additonal information
Responsible Party: University of Taubate
ClinicalTrials.gov Identifier: NCT02215460    
Other Study ID Numbers: FMSQSPT
CEP521/10 ( Other Identifier: Institutional Ethics Committee on research involving human 521/10 )
2010/19079-8 ( Other Grant/Funding Number: Fapesp )
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Azithromycin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents