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

University of Taubate

Status and phase: Completed; Phase 4

Conditions: Periodontitis

Treatments: Drug: QS placebo rinse; Drug: FMS azithromycin tablets; Procedure: QS quadrant scaling; Drug: FMS placebo tablets; Drug: QS placebo tablets; Procedure: FMS full-mouth scaling; Drug: QS chlorhexidine rinse; Drug: FMS chlorhexidine rinse; Drug: QS azithromycin tablets; Drug: FMS placebo rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT02215460

FMSQSPT

CEP521/10 (Other Identifier)

2010/19079-8 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 10 patient groups, including a placebo group

Full-mouth scaling (FMS)

Experimental group

Treatment:

Procedure: FMS full-mouth scaling

FMS chlorhexidine rinse

Experimental group

Treatment:

Procedure: FMS full-mouth scaling

Drug: FMS chlorhexidine rinse

FMS azithromycin tablets

Experimental group

Treatment:

Procedure: FMS full-mouth scaling

Drug: FMS azithromycin tablets

FMS placebo rinse

Placebo Comparator group

Treatment:

Procedure: FMS full-mouth scaling

Drug: FMS placebo rinse

Quadrant scaling (QS)

Experimental group

Treatment:

Procedure: QS quadrant scaling

QS chlorhexidine rinse

Experimental group

Treatment:

Drug: QS chlorhexidine rinse

Procedure: QS quadrant scaling

QS azithromycin tablets

Experimental group

Treatment:

Drug: QS azithromycin tablets

Procedure: QS quadrant scaling

QS placebo tablets

Placebo Comparator group

Treatment:

Procedure: QS quadrant scaling

Drug: QS placebo tablets

FMS placebo tablets

Placebo Comparator group

Treatment:

Drug: FMS placebo tablets

Procedure: FMS full-mouth scaling

QS placebo rinse

Placebo Comparator group

Treatment:

Drug: QS placebo rinse

Procedure: QS quadrant scaling