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

Study Overview
=================
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.

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

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full-mouth scaling (FMS)<br> | Procedure: FMS full-mouth scaling<br>* 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.<br>|
| Experimental: FMS chlorhexidine rinse<br> | Procedure: FMS full-mouth scaling<br>* 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.<br>Drug: FMS chlorhexidine rinse<br>* 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.<br>|
| Experimental: FMS azithromycin tablets<br> | Procedure: FMS full-mouth scaling<br>* 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.<br>Drug: FMS azithromycin tablets<br>* 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.<br>|
| Placebo Comparator: FMS placebo rinse<br> | Procedure: FMS full-mouth scaling<br>* 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.<br>Drug: FMS placebo rinse<br>* 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.<br>|
| Experimental: Quadrant scaling (QS)<br> | Procedure: QS quadrant scaling<br>* 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.<br>|
| Experimental: QS chlorhexidine rinse<br> | Procedure: QS quadrant scaling<br>* 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.<br>Drug: QS chlorhexidine rinse<br>* 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.<br>|
| Experimental: QS azithromycin tablets<br> | Procedure: QS quadrant scaling<br>* 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.<br>Drug: QS azithromycin tablets<br>* 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.<br>|
| Placebo Comparator: QS placebo tablets<br> | Procedure: QS quadrant scaling<br>* 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.<br>Drug: QS placebo tablets<br>* 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.<br>|
| Placebo Comparator: FMS placebo tablets<br> | Procedure: FMS full-mouth scaling<br>* 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.<br>Drug: FMS placebo tablets<br>* 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.<br>|
| Placebo Comparator: QS placebo rinse<br> | Procedure: QS quadrant scaling<br>* 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.<br>Drug: QS placebo rinse<br>* 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.<br>|

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 |