Periodontal DiseasePhase 4NCT02487186
Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
A Phase 4 study testing Doxicicline and Full-mouth debridment in people with Periodontal Disease, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized periodontitis treatment. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Doxicicline and Full-mouth debridment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Jun 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic generalized periodontitis (AAP,1999);
- At least 7 sites with probing depths >5mm, and 2 sites with probing depth >7mm;
- At least 20 teeth present;
- Systemically healthy.
Who cannot join
- Had received periodontal care 6 months prior to the study;
- Had taken medications known to interfere with periodontal health and healing 6 months prior to the study;
- Pregnants or lactants;
- Smokers;
- Sensitive to doxycycline.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, 13414-903
About this study
Official title: Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized periodontitis treatment.
Read the detailed description
Thirty patients with chronic periodontitis and a minimum of seven pockets (>5
mm) in non-molars teeth that bled on probing will be selected. Patients will be randomly
assigned to ultrasonic periodontal debridement followed by local application of doxycycline
by PLGA microspheres (DB+DOX) and periodontal debridement followed by administration
of void PLGA microspheres (DB). Plaque, bleeding on probe, clinical attachment level
(CAL), and probing depth (PD) will be recorded at baseline, 3 and 6 months. Subgingival
biofilm samples will be collected from initially moderate (5 to 6 mm) and deep (≥7 mm)
pockets at baseline, 1, 3 and 6 months. Polimerase chain reaction (PCR) analysis will be
used to detect the frequency of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf),
Treponema denticola (Td), Aggregatibacter actinomycetemcomitans (Aa), and Prevotella
intermedia (Pi).
- Conditions
- Periodontal Disease
- Being tested
- Doxicicline, Full-mouth debridment
- Keywords
- Chronic periodontitis, Local doxycycline, Ultrasonic debridement, PLGA microspheres, Microbiologic assessment
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxiciclineDrug
Also called PLGA microspheres
Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
Full-mouth debridmentProcedure or surgery
The patients will be treated by a single-session of periodontal debridement
during 45 minutes, using an ultrasonic instrument (Cavitron, Dentsply, Rio de
Janeiro, Brazil), under irrigation with sterile saline solution 20. After the debridement, local administration of microspheres loading doxycycline (DOX) (test) or empty microspheres (control) was performed.
| Study group | Role | What they receive |
|---|---|---|
| Test group: DB+DOX | Active comparator | Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%. Receives: Drug: Doxicicline; Procedure: Full-mouth debridment |
| Control group: DB alone | Active comparator | Control group: DB alone (Full-mouth debridment)
Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres. Receives: Procedure: Full-mouth debridment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depht (PD)
Probing depth (PD) will be measured at six sites per tooth by a PCP-15 periodontal Probe (Hu-Friedy - Chicago, IL, USA); This measure will be performed with the use of a plastic stent, presenting edges for the positioning of the stent probe.
Measured: 6 months
Secondary outcomes (1)
Clinical attachment level (CAL)
Six sites per tooth, will be measured with a PCP-15 Periodontal Probe (Hu-Friedy - Chicago, IL, USA). This measure will be performed with the use of a plastic stent, presenting edges for the positioning of the stent probe.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startMar 2010
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enilson Antonio Sallum, University of Campinas, Brazil
- Investigators
- Enilson A Sallum, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487186
- Sponsor's protocol ID
- 012/2009
- Status last verified
- Jun 2015
- First submitted
- 26 Jun 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
- ClinicalTrials.gov ID
- NCT02487186
- Acronym / sponsor ID
- 012/2009
- Conditions
- Periodontal Disease
- Keywords
- Chronic periodontitis, Local doxycycline, Ultrasonic debridement, PLGA microspheres, Microbiologic assessment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Jul 2015 (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.
The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized periodontitis treatment.
Detailed description
Thirty patients with chronic periodontitis and a minimum of seven pockets (>5
mm) in non-molars teeth that bled on probing will be selected. Patients will be randomly
assigned to ultrasonic periodontal debridement followed by local application of doxycycline
by PLGA microspheres (DB+DOX) and periodontal debridement followed by administration
of void PLGA microspheres (DB). Plaque, bleeding on probe, clinical attachment level
(CAL), and probing depth (PD) will be recorded at baseline, 3 and 6 months. Subgingival
biofilm samples will be collected from initially moderate (5 to 6 mm) and deep (≥7 mm)
pockets at baseline, 1, 3 and 6 months. Polimerase chain reaction (PCR) analysis will be
used to detect the frequency of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf),
Treponema denticola (Td), Aggregatibacter actinomycetemcomitans (Aa), and Prevotella
intermedia (Pi).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group: DB+DOX | Active comparator | Drug: Doxicicline, Procedure: Full-mouth debridmentTest group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%. |
| Control group: DB alone | Active comparator | Procedure: Full-mouth debridmentControl group: DB alone (Full-mouth debridment) Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chronic generalized periodontitis (AAP,1999);
- At least 7 sites with probing depths >5mm, and 2 sites with probing depth >7mm;
- At least 20 teeth present;
- Systemically healthy.
Key exclusion criteria (5 listed)
- Had received periodontal care 6 months prior to the study;
- Had taken medications known to interfere with periodontal health and healing 6 months prior to the study;
- Pregnants or lactants;
- Smokers;
- Sensitive to doxycycline.
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 |
|---|---|---|
| DoxiciclineAlso: PLGA microspheresAssociation of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis. | Drug | Test group: DB+DOX |
| Full-mouth debridmentThe patients will be treated by a single-session of periodontal debridement during 45 minutes, using an ultrasonic instrument (Cavitron, Dentsply, Rio de Janeiro, Brazil), under irrigation with sterile saline solution 20. After the debridement, local administration of microspheres loading doxycycline (DOX) (test) or empty microspheres (control) was performed. | Procedure or surgery | Control group: DB alone, Test group: DB+DOX |
Primary outcome
Probing depht (PD)
Time frame: 6 months
Probing depth (PD) will be measured at six sites per tooth by a PCP-15 periodontal Probe (Hu-Friedy - Chicago, IL, USA); This measure will be performed with the use of a plastic stent, presenting edges for the positioning of the stent probe.
1 secondary outcome
Clinical attachment level (CAL)
Time frame: 6 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 31 Mar 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.
Enilson A Sallum, PhD principal investigator
University of Campinas, Brazil
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 Doxicicline and Full-mouth debridment in people with Periodontal Disease, run by University of Campinas, Brazil 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 4 inclusion and 5 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 31 Mar 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 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. 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 depht (PD) (time frame: 6 months). 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 31 Mar 2016.