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Completed

NCT Number: NCT02215460

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nucleus of periodontal research of University of Taubate

Taubaté, São Paulo, 12020330, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FMS full-mouth scaling

Procedure

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.

QS quadrant scaling

Procedure

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.

FMS chlorhexidine rinse

Drug

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.

FMS placebo rinse

Drug

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.

FMS azithromycin tablets

Drug

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.

FMS placebo tablets

Drug

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.

QS azithromycin tablets

Drug

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.

QS placebo tablets

Drug

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.

QS chlorhexidine rinse

Drug

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.

QS placebo rinse

Drug

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.

Primary outcomes

  1. Improvements in pocket depth and clinical attachment level measurements

    Time frame: 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 outcomes

  1. Improvements in plaque index and gingival index

    Time frame: Changes from baseline to 3 months

    Improvements in plaque index (scores) and gingival index (scores) when baseline data was compared to 3 months data.

  2. Maintenance of pocket depth and clinical attachment level measurements

    Time frame: 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.

  3. Changes in total bacterial load and levels of selected pathogens

    Time frame: 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.

  4. Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines

    Time frame: 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.

Other outcomes

  1. Impact of periodontal treatment on quality of life

    Time frame: 6 and 9 months

    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

  2. Impact of periodontal disease on quality of life

    Time frame: Baseline

    The expected negative effect of periodontal disease on quality of life (score) was measured by analyzing baseline data.

  3. Dental Anxiety experience

    Time frame: Baseline

    Dental Anxiety (score) was measured immediately before treatment.

  4. Experience of pain

    Time frame: at the second day for full-mouth scaling groups; or at month for quadrant scaling groups.

    Experience of pain (scale) due to type of scaling was evaluated immediately after treatment.

  5. Changes in nitrite levels

    Time frame: 6 months

    Changes in nitrite levels (mean values) in saliva was determined by comparing baseline and 6 months values.

  6. Improvements in organoleptic and volatile sulphur compounds measurements

    Time frame: 3 months

    The expected positive impact of periodontal treatment on organoleptic (score) and volatile sulphur compounds (mean values) measurements were evaluated at 3 months.

Sponsors and collaborators

Lead sponsor

University of Taubate

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2014
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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