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

Effectiveness of Two Non-surgical Periodontal Treatment Protocols: Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: FMS full-mouth scaling; Drug: FMS chlorhexidine rinse; Drug: FMS azithromycin tablets; Drug: FMS placebo rinse; Procedure: QS quadrant scaling; Drug: QS chlorhexidine rinse; Drug: QS azithromycin tablets; Drug: QS placebo tablets; Drug: FMS placebo tablets; Drug: QS placebo rinse

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Taubate, SP, Brazil, 12020330
      • Nucleus of periodontal research of University of Taubate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Changes from baseline to 3 months
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 pocket depth and clinical attachment level from 6 months to 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.	3 months
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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of periodontal treatment on quality of life	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	6 and 9 months
Impact of periodontal disease on quality of life	The expected negative effect of periodontal disease on quality of life (score) was measured by analyzing baseline data.	Baseline
Dental Anxiety experience	Dental Anxiety (score) was measured immediately before treatment.	Baseline
Experience of pain	Experience of pain (scale) due to type of scaling was evaluated immediately after treatment.	at the second day for full-mouth scaling groups; or at month for quadrant scaling groups.
Changes in nitrite levels	Changes in nitrite levels (mean values) in saliva was determined by comparing baseline and 6 months values.	6 months
Improvements in organoleptic and volatile sulphur compounds measurements	The expected positive impact of periodontal treatment on organoleptic (score) and volatile sulphur compounds (mean values) measurements were evaluated at 3 months.	3 months

Collaborators and Investigators

• Sponsor: University of Taubate
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 13, 2014

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Anti-Bacterial Agents; Disinfectants; Chlorhexidine; Azithromycin; Chlorhexidine gluconate
• 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)