PeriodontitisPhase 4NCT02215460
Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours
A Phase 4 study testing FMS full-mouth scaling, QS quadrant scaling and FMS chlorhexidine rinse in people with Periodontitis, run by University of Taubate at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- FMS full-mouth scaling, QS quadrant scaling and FMS chlorhexidine rinse
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2012to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mild to moderate chronic periodontitis;
- at least 20 natural teeth;
- good general health
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Nucleus of periodontal research of University of Taubate
Taubaté, São Paulo, 12020330
About this study
Official title: Effectiveness of Two Non-surgical Periodontal Treatment Protocols: Randomized Controlled Clinical Trial
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.
- Conditions
- Periodontitis
- Being tested
- FMS full-mouth scaling, QS quadrant scaling, FMS chlorhexidine rinse, FMS placebo rinse, FMS azithromycin tablets
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMS full-mouth scalingProcedure or surgery
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 scalingProcedure or surgery
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 rinseDrug
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 rinseDrug
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 tabletsDrug
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 tabletsDrug
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 tabletsDrug
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 tabletsDrug
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 rinseDrug
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 rinseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Full-mouth scaling (FMS) | Experimental | Not described Receives: Procedure: FMS full-mouth scaling |
| FMS chlorhexidine rinse | Experimental | Not described Receives: Procedure: FMS full-mouth scaling; Drug: FMS chlorhexidine rinse |
| FMS azithromycin tablets | Experimental | Not described Receives: Procedure: FMS full-mouth scaling; Drug: FMS azithromycin tablets |
| FMS placebo rinse | Placebo comparator | Not described Receives: Procedure: FMS full-mouth scaling; Drug: FMS placebo rinse |
| Quadrant scaling (QS) | Experimental | Not described Receives: Procedure: QS quadrant scaling |
| QS chlorhexidine rinse | Experimental | Not described Receives: Procedure: QS quadrant scaling; Drug: QS chlorhexidine rinse |
| QS azithromycin tablets | Experimental | Not described Receives: Procedure: QS quadrant scaling; Drug: QS azithromycin tablets |
| QS placebo tablets | Placebo comparator | Not described Receives: Procedure: QS quadrant scaling; Drug: QS placebo tablets |
| FMS placebo tablets | Placebo comparator | Not described Receives: Procedure: FMS full-mouth scaling; Drug: FMS placebo tablets |
| QS placebo rinse | Placebo comparator | Not described Receives: Procedure: QS quadrant scaling; Drug: QS placebo rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes in pocket depth and clinical attachment level measurements from baseline to 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Taubate
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215460
- Sponsor's protocol ID
- FMSQSPT
- Other IDs
- CEP521/10, 2010/19079-8
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
Publications
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.
CORTELLI JR. et al. Clinical/Microbiological Comparative Effects between Full-mouth and Quadrant Debridement plus Chlorhexidine. In: IADR, 2013, SEATTLE. IADR, 2013.
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Non-surgical Periodontal Treatment Protocols: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02215460
- Acronym / sponsor ID
- FMSQSPT
- Conditions
- Periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of TaubateUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Full-mouth scaling (FMS) | Experimental | Procedure: FMS full-mouth scaling |
| FMS chlorhexidine rinse | Experimental | Procedure: FMS full-mouth scaling, Drug: FMS chlorhexidine rinse |
| FMS azithromycin tablets | Experimental | Procedure: FMS full-mouth scaling, Drug: FMS azithromycin tablets |
| FMS placebo rinse | Placebo comparator | Procedure: FMS full-mouth scaling, Drug: FMS placebo rinse |
| Quadrant scaling (QS) | Experimental | Procedure: QS quadrant scaling |
| QS chlorhexidine rinse | Experimental | Procedure: QS quadrant scaling, Drug: QS chlorhexidine rinse |
| QS azithromycin tablets | Experimental | Procedure: QS quadrant scaling, Drug: QS azithromycin tablets |
| QS placebo tablets | Placebo comparator | Procedure: QS quadrant scaling, Drug: QS placebo tablets |
| FMS placebo tablets | Placebo comparator | Procedure: FMS full-mouth scaling, Drug: FMS placebo tablets |
| QS placebo rinse | Placebo comparator | Procedure: QS quadrant scaling, Drug: QS placebo rinse |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- mild to moderate chronic periodontitis;
- at least 20 natural teeth;
- good general health
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMS full-mouth scalingParticipants 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. | Procedure or surgery | FMS azithromycin tablets, FMS chlorhexidine rinse, FMS placebo rinse, FMS placebo tablets, Full-mouth scaling (FMS) |
| QS quadrant scalingParticipants 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. | Procedure or surgery | QS azithromycin tablets, QS chlorhexidine rinse, QS placebo rinse, QS placebo tablets, Quadrant scaling (QS) |
| FMS chlorhexidine rinseParticipants 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. | Drug | FMS chlorhexidine rinse |
| FMS placebo rinseParticipants 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. | Drug | FMS placebo rinse |
| FMS azithromycin tabletsParticipants 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. | Drug | FMS azithromycin tablets |
| FMS placebo tabletsParticipants 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. | Drug | FMS placebo tablets |
| QS azithromycin tabletsParticipants 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. | Drug | QS azithromycin tablets |
| QS placebo tabletsParticipants 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. | Drug | QS placebo tablets |
| QS chlorhexidine rinseParticipants 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. | Drug | QS chlorhexidine rinse |
| QS placebo rinseParticipants 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. | Drug | QS placebo rinse |
Primary outcome
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.
4 secondary outcomes
Improvements in plaque index and gingival index
Time frame: Changes from baseline to 3 months
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
Changes in total bacterial load and levels of selected pathogens
Time frame: 3 months
Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Results publicationCortelli 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.
- Results publicationCORTELLI JR. et al. Clinical/Microbiological Comparative Effects between Full-mouth and Quadrant Debridement plus Chlorhexidine. In: IADR, 2013, SEATTLE. IADR, 2013.
- Results publicationCORTELLI 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FMS full-mouth scaling, QS quadrant scaling and FMS chlorhexidine rinse in people with Periodontitis, run by University of Taubate at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02215460, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.