Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours
- Conditions
- Periodontitis
- Interventions
- Procedure: FMS full-mouth scalingProcedure: QS quadrant scalingDrug: QS placebo rinseDrug: FMS placebo tabletsDrug: FMS placebo rinseDrug: QS placebo tablets
- Registration Number
- NCT02215460
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- mild to moderate chronic periodontitis;
- at least 20 natural teeth;
- good general health
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FMS chlorhexidine rinse FMS full-mouth scaling - FMS azithromycin tablets FMS full-mouth scaling - FMS azithromycin tablets FMS azithromycin tablets - FMS chlorhexidine rinse FMS chlorhexidine rinse - Full-mouth scaling (FMS) FMS full-mouth scaling - QS placebo rinse QS placebo rinse - Quadrant scaling (QS) QS quadrant scaling - QS chlorhexidine rinse QS chlorhexidine rinse - FMS placebo tablets FMS placebo tablets - FMS placebo rinse FMS full-mouth scaling - FMS placebo rinse FMS placebo rinse - QS chlorhexidine rinse QS quadrant scaling - QS placebo tablets QS placebo tablets - QS azithromycin tablets QS quadrant scaling - QS azithromycin tablets QS azithromycin tablets - QS placebo tablets QS quadrant scaling - FMS placebo tablets FMS full-mouth scaling - QS placebo rinse QS quadrant scaling -
- Primary Outcome Measures
Name Time Method Improvements in pocket depth and clinical attachment level measurements 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
Name Time Method Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines 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.
Changes in total bacterial load and levels of selected pathogens 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.
Improvements in plaque index and gingival index Changes from baseline to 3 months 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 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.
Trial Locations
- Locations (1)
Nucleus of periodontal research of University of Taubate
🇧🇷Taubate, SP, Brazil