Chronic PeriodontitisPhase 4NCT02355977
The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis
A Phase 4 study testing minocycline and surface and root planning in people with Chronic Periodontitis, run by Zhejiang University.
Trial summary
To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- minocycline and surface and root planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding on probing and attachment loss, with radiographic alveolar bone loss in four or more teeth
Who cannot join
- pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months or had systemic diseases such as heart disease or hypertension
About this study
Official title: The Response of Periodontal Pathogens to the Respective or Combined Treatment of Scaling and Root Planning and Locally Delivered Minocycline in Patients With Chronic Periodontitis- a Short-term Randomized Clinical Trial
To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis.
Read the detailed description
In this randomized clinical trial, the investigators will evaluate the respective or combinatory efficacy of minocycline and scaling and root planning in the aspects of both clinical parameters [Pocket depth (PD) and sulcus bleeding index (SBI)] and the loads of four main periodontal pathogens [Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg) and Prevotella intermedia (Pi)]. Real-time quantitative PCR (qRT-PCR) will be used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria in a period of 7 days. The investigators will also try to correlate the reduction of either total or respective bacteria with the improvements of clinical parameters, with an aim to uncovering the potential microbiological mechanism accounting for the efficacy of a therapy.
- Conditions
- Chronic Periodontitis
- Being tested
- minocycline, surface and root planning
- Keywords
- Chronic periodontitis, Minocycline, Surface and root planning, Pocket depth, Sulcus bleeding index, Prevotella intermedia
- Medical subject headings
- Chronic Periodontitis, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minocyclineDrug
Also called Periocline dental ointment
Periocline dental ointment
surface and root planningProcedure or surgery
surface and root planning
| Study group | Role | What they receive |
|---|---|---|
| surface and root planning | Active comparator | surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France) Receives: Procedure: surface and root planning |
| locally delivered minocycline | Active comparator | Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth Receives: Drug: minocycline; Procedure: surface and root planning |
| surface and root planning+minocycline | Experimental | surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline. Receives: Drug: minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket Depth
PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.
Measured: 7 days
Secondary outcomes (2)
Bleeding on Probing
BOP is evaluated for the treated tooth using the sulcus bleeding index (SBI) by Muhlemann with a range of 0 (no bleeding) to 5 (profuse bleeding)
Measured: 7 days
Bacterial Load
Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Responsible party
- Principal investigator, Shuli Deng, Zhejiang University
- Investigators
- Shuli Deng, Master, Principal investigator, Affiliated Hospital of Stomatology, Medical College, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355977
- Sponsor's protocol ID
- 2013-25
- Status last verified
- Oct 2015
- First submitted
- 31 Jan 2015
- Last updated
- 2 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Response of Periodontal Pathogens to the Respective or Combined Treatment of Scaling and Root Planning and Locally Delivered Minocycline in Patients With Chronic Periodontitis- a Short-term Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02355977
- Acronym / sponsor ID
- 2013-25
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic periodontitis, Minocycline, Surface and root planning, Pocket depth, Sulcus bleeding index, Prevotella intermedia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Posted 2 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis.
Detailed description
In this randomized clinical trial, the investigators will evaluate the respective or combinatory efficacy of minocycline and scaling and root planning in the aspects of both clinical parameters [Pocket depth (PD) and sulcus bleeding index (SBI)] and the loads of four main periodontal pathogens [Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg) and Prevotella intermedia (Pi)]. Real-time quantitative PCR (qRT-PCR) will be used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria in a period of 7 days. The investigators will also try to correlate the reduction of either total or respective bacteria with the improvements of clinical parameters, with an aim to uncovering the potential microbiological mechanism accounting for the efficacy of a therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| surface and root planning | Active comparator | Procedure: surface and root planningsurface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France) |
| locally delivered minocycline | Active comparator | Drug: minocycline, Procedure: surface and root planningLocally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth |
| surface and root planning+minocycline | Experimental | Drug: minocyclinesurface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding on probing and attachment loss, with radiographic alveolar bone loss in four or more teeth
Key exclusion criteria (1 listed)
- pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months or had systemic diseases such as heart disease or hypertension
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 |
|---|---|---|
| minocyclineAlso: Periocline dental ointmentPeriocline dental ointment | Drug | locally delivered minocycline, surface and root planning+minocycline |
| surface and root planningsurface and root planning | Procedure or surgery | locally delivered minocycline, surface and root planning |
Primary outcome
Pocket Depth
Time frame: 7 days
PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.
2 secondary outcomes
Bleeding on Probing
Time frame: 7 days
Bacterial Load
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shuli Deng, Master principal investigator
Affiliated Hospital of Stomatology, Medical College, Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing minocycline and surface and root planning in people with Chronic Periodontitis, run by Zhejiang University.
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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 2 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pocket Depth (time frame: 7 days). 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 Dec 2015.