Periodontal PocketPhase 4NCT02023840
The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis
A Phase 4 study testing metronidazole gel, ultrasonics and erythritol in people with Periodontal Pocket, run by Proed, Torino, Italy at 1 site in Italy.
Trial summary
Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets. 20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- metronidazole gel, ultrasonics and erythritol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients suffering from periodontitis at least 4 sites with probing pocket depth =>4mm
Who cannot join
- Heavy smokers current pregnant patients history of malignancy Long term steroidal or antibiotic therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
PROED, Institute for Professional Education in Dentistry
Torino, 10129
About this study
Official title: The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Periodontitis: a Split-mouth Randomized Controlled Clinical Trial
Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets.
20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be enrolled. For each patients four sites will be considered for the study, and two sites will be allocated in the test group and two sites will be allocated in the control group. In the test group, ultrasonic debridement of the pocket will be performed using a piezoceramic ultrasonic device with the a tip connected to the handpiece for 5 minutes/pocket. Then, it will be followed by the subgingival use of erythritol powder 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. In the control group, the same protocol will be used except for the use of a placebo instead of metronidazole. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.
At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).
Read the detailed description
The long term results and benefit of infection control in the treatment of periodontal disease have been well documented. According to a cause-related concept, the disruption of bacterial plaque biofilms can be defined as primary objective for the treatment of periodontitis.
In the past few years, glycine powder air polishing showed positive outcomes in removing subgingival biofilm in periodontal pockets, and subgingivally delivered metronidazole seemed to improve the results of scaling and root-planing alone . Recently, a new prophylactic powder has been developed. The special action of the powder is attributable to the new ingredient Erythritol and the extra-fine grains that measure only 14 microns. The small size results on one hand in a minimal impact per grain on the treated surface and on the other hand in a very dense jet of powder, efficient on biofilm.
Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets.
MATERIALS \& METHODS:
20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be enrolled. For each patients four sites will be considered for the study, and two sites will be allocated in the test group and two sites will be allocated in the control group. In the test group, ultrasonic debridement of the pocket will be performed using a piezoceramic ultrasonic device with the tip connected to the Handpiece Led for 5 minutes/pocket. Then, it will be followed by the subgingival use of erythritol powder applied by the use of Perio-Flow Handpiece with Perio-Flow Nozzle, connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. In the control group, the same protocol will be used except for the use of a placebo instead of metronidazole. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.
At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).
- Conditions
- Periodontal Pocket
- Being tested
- metronidazole gel, ultrasonics, erythritol, placebo
- Keywords
- periodontitis, pockets
- Medical subject headings
- Periodontal Pocket, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metronidazole gelDrug
ultrasonicsProcedure or surgery
erythritolProcedure or surgery
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| ultrasonics and erythritol, metronidazole gel | Active comparator | Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of metronidazole gel Receives: Drug: metronidazole gel; Procedure: ultrasonics; Procedure: erythritol |
| ultrasonics and erythritol, placebo | Placebo comparator | Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of placebo Receives: Procedure: ultrasonics; Procedure: erythritol; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket Depth change
Using a periodontal calibrated PCP-15 mm probe, the pocket depth will be measured
Measured: baseline, 6 months
Bleeding on Probing change
Using a periodontal calibrated PCP-15 mm probe, the bleeding on probing will be detected
Measured: baseline, 6 months
Clinical Attachment level change
Using a periodontal calibrated PCP-15 mm probe, the attachment level will be measured
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proed, Torino, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Cardaropoli, DDS, Principal investigator, Proed, Torino, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023840
- Sponsor's protocol ID
- 07.2013.ERYTHRITOL.PROED
- Status last verified
- Sep 2016
- First submitted
- 18 Dec 2013
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Periodontitis: a Split-mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02023840
- Acronym / sponsor ID
- 07.2013.ERYTHRITOL.PROED
- Conditions
- Periodontal Pocket
- Keywords
- periodontitis, pockets
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Proed, Torino, ItalyUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Dec 2013 (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.
Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets.
20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be enrolled. For each patients four sites will be considered for the study, and two sites will be allocated in the test group and two sites will be allocated in the control group. In the test group, ultrasonic debridement of the pocket will be performed using a piezoceramic ultrasonic device with the a tip connected to the handpiece for 5 minutes/pocket. Then, it will be followed by the subgingival use of erythritol powder 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. In the control group, the same protocol will be used except for the use of a placebo instead of metronidazole. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.
At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).
Detailed description
The long term results and benefit of infection control in the treatment of periodontal disease have been well documented. According to a cause-related concept, the disruption of bacterial plaque biofilms can be defined as primary objective for the treatment of periodontitis.
In the past few years, glycine powder air polishing showed positive outcomes in removing subgingival biofilm in periodontal pockets, and subgingivally delivered metronidazole seemed to improve the results of scaling and root-planing alone . Recently, a new prophylactic powder has been developed. The special action of the powder is attributable to the new ingredient Erythritol and the extra-fine grains that measure only 14 microns. The small size results on one hand in a minimal impact per grain on the treated surface and on the other hand in a very dense jet of powder, efficient on biofilm.
Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets.
MATERIALS \& METHODS:
20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be enrolled. For each patients four sites will be considered for the study, and two sites will be allocated in the test group and two sites will be allocated in the control group. In the test group, ultrasonic debridement of the pocket will be performed using a piezoceramic ultrasonic device with the tip connected to the Handpiece Led for 5 minutes/pocket. Then, it will be followed by the subgingival use of erythritol powder applied by the use of Perio-Flow Handpiece with Perio-Flow Nozzle, connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. In the control group, the same protocol will be used except for the use of a placebo instead of metronidazole. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.
At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasonics and erythritol, metronidazole gel | Active comparator | Drug: metronidazole gel, Procedure: ultrasonics, Procedure: erythritolScaling and root planing with ultrasonics and erythritol air powder will be followed by application of metronidazole gel |
| ultrasonics and erythritol, placebo | Placebo comparator | Procedure: ultrasonics, Procedure: erythritol, Drug: placeboScaling and root planing with ultrasonics and erythritol air powder will be followed by application of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients suffering from periodontitis at least 4 sites with probing pocket depth =>4mm
Key exclusion criteria (1 listed)
- Heavy smokers current pregnant patients history of malignancy Long term steroidal or antibiotic therapy
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 |
|---|---|---|
| metronidazole gel | Drug | ultrasonics and erythritol, metronidazole gel |
| ultrasonics | Procedure or surgery | ultrasonics and erythritol, metronidazole gel, ultrasonics and erythritol, placebo |
| erythritol | Procedure or surgery | ultrasonics and erythritol, metronidazole gel, ultrasonics and erythritol, placebo |
| placebo | Drug | ultrasonics and erythritol, placebo |
Primary outcome
Probing pocket Depth change
Time frame: baseline, 6 months
Using a periodontal calibrated PCP-15 mm probe, the pocket depth will be measured
Bleeding on Probing change
Time frame: baseline, 6 months
Using a periodontal calibrated PCP-15 mm probe, the bleeding on probing will be detected
Clinical Attachment level change
Time frame: baseline, 6 months
Using a periodontal calibrated PCP-15 mm probe, the attachment level will be measured
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 2 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Daniele Cardaropoli, DDS principal investigator
Proed, Torino, Italy
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 metronidazole gel, ultrasonics and erythritol in people with Periodontal Pocket, run by Proed, Torino, Italy at 1 site in Italy.
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 1 inclusion and 1 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 2 Sep 2016. 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 Italy. 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?
Probing pocket Depth change (time frame: baseline, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2016.