Periodontitis, AdultPhase 4NCT04076098
Locally Delivered Minocycline in Advanced Periodontitis
A Phase 4 study testing Minocycline Hydrochloride in people with Periodontitis, Adult, run by Mahsa University at 1 site in Malaysia.
Trial summary
Local drug delivery provides higher concentrations in the availability of the drug at the specific infected sites with the advantage of sustained release. Periocline is a long acting , sustained release local drug delivery system consisting of 2% minocycline hydrochloride in an ointment containing microcapsule type… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- Minocycline Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- 25 Jun 2018to 20 Sep 2021
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systematically healthy patients with age range between 20- 60 years,
- diagnosed with untreated Advanced Periodontitis with a pocket depth ≥6mm around two or more teeth, in two or more quadrants.
Who cannot join
- Patients given antibiotics or anti-inflammatory drugs in the past 6 months,
- allergic to tetracycline,
- pregnant or nursing females,
- those using chlorhexidine or any other mouth rinse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Locally Delivered Minocycline in Advanced Periodontitis. A Clinico-microbiological Study
Local drug delivery provides higher concentrations in the availability of the drug at the specific infected sites with the advantage of sustained release. Periocline is a long acting , sustained release local drug delivery system consisting of 2% minocycline hydrochloride in an ointment containing microcapsule type particles. Periocline contains 20mg of minocycline in 0.5 gm of gel in a disposable polypropylene applicator (2% minocycline HCl).
Research has yielded promising results with the local application of minocycline in the treatment of periodontal disease, compared with other non-surgical therapies. However, there is scarcity of reports on the use of local delivery agents with respect to new range of putative pathogens in advanced periodontitis, wherein the tissue invasive anaerobic organisms are present and possibly compromised host response, hence resulting in an exaggerated breakdown of periodontal tissues at the affected sites. The effect of Minocycline on new putative pathogens, such as Filifactor alocis and oral phylotypes of phyla Synergistetes and TM7 (referred to hereafter as oral Synergistetes and oral TM7s), has not been investigated yet.
Hence, the aim of the present study is to evaluate the efficacy of a local delivery agent containing minocycline (Periocline, Sunstar, Japan) as an adjunct to SRP in the treatment of deep periodontal pockets around teeth in advanced periodontitis and the antimicrobial effect on the red complex and the new putative pathogens.
Read the detailed description
The subjects for this randomized controlled, parallel arm study will be selected from the primary health care in the Faculty of Dentistry, MAHSA University. In this clinical trial, 50 patients with advanced periodontitis will be enrolled in the study.
- Conditions
- Periodontitis, Adult
- Being tested
- Minocycline Hydrochloride
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline HydrochlorideDrug
Also called Periocline
Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Minocycline gel Receives: Drug: Minocycline Hydrochloride |
| Placebo | Placebo comparator | Similar gel without the active agent Receives: Drug: Minocycline Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing pocket depth (PPD)
Periodontal pocket is measured from the gingival margin to the base of the periodontal pocket using a UNC periodontal probe (which is graduated from 1mm to 15mm). The measurement of periodontal pocket depth is a continuous scale. PPD is taken at 6 points on each tooth. The mean of the PPD will be obtained for each patient and subjected to statistical analysis.
Measured: baseline to 12 weeks
Change in the numbers of Periodontal pathogens
Plaque samples taken from periodontal pockets on paper points will be first stored and later analysed for the presence and number of periopathogens using quantative Polymerase Chain Reaction (q-PCR).
The following periodontal pathogens will be assessed:
- Red complex (Porphyromonas gingivalis, Tannerella forsythia,and Treponema denticola)
- Filifactor alocis,
- oral phylotypes of phyla Synergistetes
- Phylum TM7
Measured: baseline to 12 weeks
Clinical Attachment Levels (CAL)
change in CAL
Measured: baseline, 6 weeks and 12 weeks
Secondary outcomes (2)
Plaque Index
change in Plaque scores (Silness and Loe Plaque index, 1964) The score ranges from 0-3 and it is a continuous scale. '0' - no plaque '1' - thin plaque which is not visible by naked eye '2' - Moderate accumulation plaque seen by naked eye '3' - abundance of plaque.
Calculation total score /number of surfaces examined = Index score for each patient. Mean plaque score is calculated for all the patients.
Measured: baseline to 12 weeks
Bleeding Index
change in Bleeding scores (Papillary bleeding index, Muehlemann 1977) The score ranges from 0-4 and it is a continuous scale. '0' - no bleeding '1' - Single discrete bleeding point '2' - Single line of blood appears '3' - Interdental papilla fills with blood after probing '4' - profuse bleeding after probing
Calculation total score /number of surfaces examined = Index score for each patient. Mean plaque score is calculated for all the patients.
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start25 Jun 2018
- Primary completion28 Dec 2020
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahsa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor. Dr. Tara Bai Taiyeb Ali, Mahsa University
- Investigators
- Tara Taiyeb Ali, MSc, FDSRCS, Principal investigator, Mahsa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076098
- Sponsor's protocol ID
- RP139-02/18
- Status last verified
- Sep 2021
- First submitted
- 2 Aug 2019
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Locally Delivered Minocycline in Advanced Periodontitis. A Clinico-microbiological Study
- ClinicalTrials.gov ID
- NCT04076098
- Acronym / sponsor ID
- RP139-02/18
- Conditions
- Periodontitis, Adult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahsa UniversityUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 3 Sep 2019 (actual)
- 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.
Local drug delivery provides higher concentrations in the availability of the drug at the specific infected sites with the advantage of sustained release. Periocline is a long acting , sustained release local drug delivery system consisting of 2% minocycline hydrochloride in an ointment containing microcapsule type particles. Periocline contains 20mg of minocycline in 0.5 gm of gel in a disposable polypropylene applicator (2% minocycline HCl).
Research has yielded promising results with the local application of minocycline in the treatment of periodontal disease, compared with other non-surgical therapies. However, there is scarcity of reports on the use of local delivery agents with respect to new range of putative pathogens in advanced periodontitis, wherein the tissue invasive anaerobic organisms are present and possibly compromised host response, hence resulting in an exaggerated breakdown of periodontal tissues at the affected sites. The effect of Minocycline on new putative pathogens, such as Filifactor alocis and oral phylotypes of phyla Synergistetes and TM7 (referred to hereafter as oral Synergistetes and oral TM7s), has not been investigated yet.
Hence, the aim of the present study is to evaluate the efficacy of a local delivery agent containing minocycline (Periocline, Sunstar, Japan) as an adjunct to SRP in the treatment of deep periodontal pockets around teeth in advanced periodontitis and the antimicrobial effect on the red complex and the new putative pathogens.
Detailed description
The subjects for this randomized controlled, parallel arm study will be selected from the primary health care in the Faculty of Dentistry, MAHSA University. In this clinical trial, 50 patients with advanced periodontitis will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: Minocycline HydrochlorideMinocycline gel |
| Placebo | Placebo comparator | Drug: Minocycline HydrochlorideSimilar gel without the active agent |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- systematically healthy patients with age range between 20- 60 years,
- diagnosed with untreated Advanced Periodontitis with a pocket depth ≥6mm around two or more teeth, in two or more quadrants.
Key exclusion criteria (4 listed)
- Patients given antibiotics or anti-inflammatory drugs in the past 6 months,
- allergic to tetracycline,
- pregnant or nursing females,
- those using chlorhexidine or any other mouth rinse
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 |
|---|---|---|
| Minocycline HydrochlorideAlso: PerioclineAdministration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets | Drug | Minocycline, Placebo |
Primary outcome
Change in Probing pocket depth (PPD)
Time frame: baseline to 12 weeks
Periodontal pocket is measured from the gingival margin to the base of the periodontal pocket using a UNC periodontal probe (which is graduated from 1mm to 15mm). The measurement of periodontal pocket depth is a continuous scale. PPD is taken at 6 points on each tooth. The mean of the PPD will be obtained for each patient and subjected to statistical analysis.
Change in the numbers of Periodontal pathogens
Time frame: baseline to 12 weeks
Plaque samples taken from periodontal pockets on paper points will be first stored and later analysed for the presence and number of periopathogens using quantative Polymerase Chain Reaction (q-PCR). The following periodontal pathogens will be assessed: * Red complex (Porphyromonas gingivalis, Tannerella forsythia,and Treponema denticola) * Filifactor alocis, * oral phylotypes of phyla Synergistetes * Phylum TM7
Clinical Attachment Levels (CAL)
Time frame: baseline, 6 weeks and 12 weeks
change in CAL
2 secondary outcomes
Plaque Index
Time frame: baseline to 12 weeks
Bleeding Index
Time frame: baseline to 12 weeks
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 23 Sep 2021.
- 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.
Tara Taiyeb Ali, MSc, FDSRCS principal investigator
Mahsa University
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 Minocycline Hydrochloride in people with Periodontitis, Adult, run by Mahsa University at 1 site in Malaysia.
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 2 inclusion and 4 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 23 Sep 2021. 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 Malaysia. 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?
Change in Probing pocket depth (PPD) (time frame: baseline to 12 weeks). 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 23 Sep 2021.