Clinical trial NCT02215460: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Lead sponsor: University of Taubate
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-08-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Improvements in pocket depth and clinical attachment level measurements
timeFrame: Changes in pocket depth and clinical attachment level measurements from baseline to 6 months
Secondary outcomes:
measure: Improvements in plaque index and gingival index
timeFrame: Changes from baseline to 3 months
measure: Maintenance of pocket depth and clinical attachment level measurements
timeFrame: Changes in pocket depth and clinical attachment level from 6 months to 9 months
measure: Changes in total bacterial load and levels of selected pathogens
timeFrame: 3 months
measure: Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines
timeFrame: 3 months
Other outcomes:
measure: Impact of periodontal treatment on quality of life
timeFrame: 6 and 9 months
measure: Impact of periodontal disease on quality of life
timeFrame: Baseline
measure: Dental Anxiety experience
timeFrame: Baseline
measure: Experience of pain
timeFrame: at the second day for full-mouth scaling groups; or at month for quadrant scaling groups.
measure: Changes in nitrite levels
timeFrame: 6 months
measure: Improvements in organoleptic and volatile sulphur compounds measurements
timeFrame: 3 months
Locations:
city: Taubate
country: Brazil
facility: Nucleus of periodontal research of University of Taubate
state: SP
Study officials:
References:
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.
citation: CORTELLI JR. et al. Clinical/Microbiological Comparative Effects between Full-mouth and Quadrant Debridement plus Chlorhexidine. In: IADR, 2013, SEATTLE. IADR, 2013.
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.