PeriodontitisPhase 4NCT04036890
Local Minocycline in Patients Under Supportive Periodontal Therapy
A Phase 4 study of Periodontitis, run by National Dental Centre, Singapore.
Trial summary
The aims of the present study are to assess the significance of the adjunctive effect of the subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison to subgingival instrumentation with application of a placebo gel, 3 months after therapy in subjects with recurrent… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Periodontitis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2016to 18 Oct 2019
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically healthy adults (ASA classification I-II)
- At least 21 years of age.
- Previously diagnosed with moderate to severe periodontitis and had completed at least 1 round of periodontal therapy including scaling and root-planing, oral hygiene instructions.
- Treated periodontitis patients undergoing maintenance care for at least 6 months.
- Ability to comply with 12-month study follow-up.
- Recurrent moderate to severe periodontitis with no previous systemic antibiotic therapy during initial periodontal therapy.
- At least 4 teeth present with residual PPD of ≥ 5 mm on each and a positive bleeding on probing (BOP).
Who cannot join
- Medically compromised subjects (ASA classification III-V).
- Known allergy or other severe adverse reactions to minocycline and related drugs.
- Patients who reported local and/or systemic antibiotic therapy within 3 months prior to baseline examination of the study, and were placed on antibiotics during active initial periodontal therapy.
- Patients with a plaque control record > 30%.
- Patients who had history of surgical periodontal treatment less than 5 years in the area with lesions.
- Pregnant or intend to conceive or are breast feeding.
About this study
Official title: Effects of Local Minocycline Adjunctive Application in Comparison to Instrumentation Alone, in Patients With Residual Pockets Under Supportive Periodontal Therapy: a Double-blinded Randomized Controlled Clinical Trial
The aims of the present study are to assess the significance of the adjunctive effect of the subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison to subgingival instrumentation with application of a placebo gel, 3 months after therapy in subjects with recurrent periodontitis undergoing supportive periodontal therapy (SPT) and to assess the substantivity of the gel attributable to the adjunctive delivery of the medication that is detected at 3 months during a 9-month period of regular SPT. Recurrent periodontitis will be defined as sites with residual periodontal probing depths and bleeding on probing after completion of initial periodontal therapy. This will include both persistent and recurrent periodontitis, where persistent means the residual periodontal site after initial periodontal therapy, and recurrent means the site which was improved by initial periodontal therapy, but disease recurred.
Read the detailed description
It has been reported that regular maintenance of subjects with treated periodontal disease is the key consideration in the long-term periodontal prognosis of these subjects. Periodic prophylaxis may prevent loss of clinical attachment over long periods of time even in patients with less than optimal plaque control. However, there are limitations in routine subgingival re-instrumentation especially in bleeding pockets, as only 50% of these sites improve. Furthermore, the persistence of bleeding pockets increases the risk of disease progression and tooth loss. Thus there is a need for adjuncts that may improve the outcome especially in subjects with recurrent periodontitis during SPT. Some studies reported significantly better results with subgingival administration of local minocycline in residual pockets post initial periodontal therapy over a short period of time. There are few studies assessing the efficacy of topical minocycline gel in subjects with recurrent periodontitis while in SPT, and the long term effect.
The present study will examine the significance of the adjunctive effect of the subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison to subgingival instrumentation with application of a placebo gel, 3 months after therapy in subjects with recurrent periodontitis undergoing supportive periodontal therapy (SPT) and to assess the substantivity of the gel attributable to the adjunctive delivery of the medication that will be detected at 3 months during a 9-month period of regular SPT.
- Conditions
- Periodontitis
- Being tested
- 2% minocycline hydrochloride controlled-delivery system (MHS), Placebos
- Keywords
- Recurrent periodontitis, Periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% minocycline hydrochloride controlled-delivery system (MHS)Drug
The test product is a highly viscous gel for local subgingival placement composing of an ointment containing micro-capsule type particles for sustained release and the active ingredient 2% minocycline gel (10mg in each syringe of 0.5g) (Periocline, SUNSTAR, Osaka, Japan). The other ingredients include magnesium chloride, hydroxyl-ethylcellulose, aminoalkylmethacrylaye copolymer, triacetin and concentrated glycerine, giving the preparation a sustained-released property. It will be applied to experimental teeth and the adjacent teeth by gently inserting the tip of a specially designed applicator until the paste flows over the gingival margin.
PlacebosDrug
It is the same gel as MHS but without active ingredient minocycline hydrochloride.
| Study group | Role | What they receive |
|---|---|---|
| 2% minocycline hydrochloride controlled-delivery system (MHS) | Experimental | Mechanical ultrasonic/ hand instrumentation and subsequent administration of MHS on that day (Day 0) and on Day 4, at 3 months, 6 months and 9 months Receives: Drug: 2% minocycline hydrochloride controlled-delivery system (MHS) |
| Placebo | Placebo comparator | Mechanical ultrasonic/ hand instrumentation and subsequent administration of a placebo gel on that day (Day 0) and on Day 4, at 3 months, 6 months and 9 months Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change of probing pocket depth (PPD)
Absolute change of PPD at 3 months compared to baseline is defined as the difference between absolute patient PPD at 3 months and absolute patient PPD at baseline. For patients who have multiple trial sites, the mean of site absolute PPD will be used as their patient PPD score.
Measured: 3 months
Secondary outcomes (5)
Absolute change of probing pocket depth (PPD)
Absolute change of PPD at 6,9 and 12 months compared to baseline are defined as the difference between absolute patient PPD at 6, 9 and 12 months and absolute patient PPD at baseline. For patients who have multiple trial sites, the mean of site absolute PPD will be used as their patient PPD score.
Measured: 6, 9,12 months
Percentage reduction of number of probing pocket depth (PPD) ≥ 5 mm
Percentage reduction of number of probing pocket depth (PPD) ≥ 5 mm at 3,6,9 and 12 months
Measured: 3, 6, 9,12 months
Reduction in bleeding on probing (BOP)
Defined as the difference between full mouth BOP score for each patient at two different study visits as well as the difference between bleeding score of the treatment sites at two different study visits. The comparison will be made between the following study visits: 3 months vs baseline, 6 months vs baseline, 9 months vs baseline, 12 months vs baseline, 3 months vs 6 months, 3 months vs 6 months, 3 months vs 9 months, and 3 months vs 12 months.
Measured: 3 months vs baseline, 6 months vs baseline, 9 months vs baseline, 12 months vs baseline, 3 months vs 6 months, 3 months vs 6 months, 3 months vs 9 months, and 3 months vs 12 months.
Change of probing attachment level (PAL)
Change of probing attachment level (PAL) at 3, 6, 9, 12 months compared to baseline are defined as the difference between patient PAL score at 3, 6, 9, 12 months and patient PAL score at baseline. For patients who have multiple trial sites, the mean of site PAL will be used as their patient PAL score.
Measured: 3, 6, 9,12 months
Incidence of recurrent rate during experimental period.
The recurrent means the case of periodontal progression (attachment loss of 2mm or more) between test and groups.
Measured: 3, 6, 9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start3 Jun 2016
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomised, double blinded trial in parallel group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Dental Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Wah Ching, National Dental Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036890
- Sponsor's protocol ID
- 196/2014
- Status last verified
- Nov 2019
- First submitted
- 25 Jul 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Local Minocycline Adjunctive Application in Comparison to Instrumentation Alone, in Patients With Residual Pockets Under Supportive Periodontal Therapy: a Double-blinded Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04036890
- Acronym / sponsor ID
- 196/2014
- Conditions
- Periodontitis
- Keywords
- Recurrent periodontitis, Periodontal therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Dental Centre, SingaporeUniversity, hospital or other
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 30 Jul 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.
The aims of the present study are to assess the significance of the adjunctive effect of the subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison to subgingival instrumentation with application of a placebo gel, 3 months after therapy in subjects with recurrent periodontitis undergoing supportive periodontal therapy (SPT) and to assess the substantivity of the gel attributable to the adjunctive delivery of the medication that is detected at 3 months during a 9-month period of regular SPT. Recurrent periodontitis will be defined as sites with residual periodontal probing depths and bleeding on probing after completion of initial periodontal therapy. This will include both persistent and recurrent periodontitis, where persistent means the residual periodontal site after initial periodontal therapy, and recurrent means the site which was improved by initial periodontal therapy, but disease recurred.
Detailed description
It has been reported that regular maintenance of subjects with treated periodontal disease is the key consideration in the long-term periodontal prognosis of these subjects. Periodic prophylaxis may prevent loss of clinical attachment over long periods of time even in patients with less than optimal plaque control. However, there are limitations in routine subgingival re-instrumentation especially in bleeding pockets, as only 50% of these sites improve. Furthermore, the persistence of bleeding pockets increases the risk of disease progression and tooth loss. Thus there is a need for adjuncts that may improve the outcome especially in subjects with recurrent periodontitis during SPT. Some studies reported significantly better results with subgingival administration of local minocycline in residual pockets post initial periodontal therapy over a short period of time. There are few studies assessing the efficacy of topical minocycline gel in subjects with recurrent periodontitis while in SPT, and the long term effect.
The present study will examine the significance of the adjunctive effect of the subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison to subgingival instrumentation with application of a placebo gel, 3 months after therapy in subjects with recurrent periodontitis undergoing supportive periodontal therapy (SPT) and to assess the substantivity of the gel attributable to the adjunctive delivery of the medication that will be detected at 3 months during a 9-month period of regular SPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double blinded trial in parallel group
| Arm | Type | Receives |
|---|---|---|
| 2% minocycline hydrochloride controlled-delivery system (MHS) | Experimental | Drug: 2% minocycline hydrochloride controlled-delivery system (MHS)Mechanical ultrasonic/ hand instrumentation and subsequent administration of MHS on that day (Day 0) and on Day 4, at 3 months, 6 months and 9 months |
| Placebo | Placebo comparator | Drug: PlacebosMechanical ultrasonic/ hand instrumentation and subsequent administration of a placebo gel on that day (Day 0) and on Day 4, at 3 months, 6 months and 9 months |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Medically healthy adults (ASA classification I-II)
- At least 21 years of age.
- Previously diagnosed with moderate to severe periodontitis and had completed at least 1 round of periodontal therapy including scaling and root-planing, oral hygiene instructions.
- Treated periodontitis patients undergoing maintenance care for at least 6 months.
- Ability to comply with 12-month study follow-up.
Key exclusion criteria (6 listed)
- Medically compromised subjects (ASA classification III-V).
- Known allergy or other severe adverse reactions to minocycline and related drugs.
- Patients who reported local and/or systemic antibiotic therapy within 3 months prior to baseline examination of the study, and were placed on antibiotics during active initial periodontal therapy.
- Patients with a plaque control record > 30%.
- Patients who had history of surgical periodontal treatment less than 5 years in the area with lesions.
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 |
|---|---|---|
| 2% minocycline hydrochloride controlled-delivery system (MHS)The test product is a highly viscous gel for local subgingival placement composing of an ointment containing micro-capsule type particles for sustained release and the active ingredient 2% minocycline gel (10mg in each syringe of 0.5g) (Periocline, SUNSTAR, Osaka, Japan). The other ingredients include magnesium chloride, hydroxyl-ethylcellulose, aminoalkylmethacrylaye copolymer, triacetin and concentrated glycerine, giving the preparation a sustained-released property. It will be applied to experimental teeth and the adjacent teeth by gently inserting the tip of a specially designed applicator until the paste flows over the gingival margin. | Drug | 2% minocycline hydrochloride controlled-delivery system (MHS) |
| PlacebosIt is the same gel as MHS but without active ingredient minocycline hydrochloride. | Drug | Placebo |
Primary outcome
Absolute change of probing pocket depth (PPD)
Time frame: 3 months
Absolute change of PPD at 3 months compared to baseline is defined as the difference between absolute patient PPD at 3 months and absolute patient PPD at baseline. For patients who have multiple trial sites, the mean of site absolute PPD will be used as their patient PPD score.
5 secondary outcomes
Absolute change of probing pocket depth (PPD)
Time frame: 6, 9,12 months
Percentage reduction of number of probing pocket depth (PPD) ≥ 5 mm
Time frame: 3, 6, 9,12 months
Reduction in bleeding on probing (BOP)
Time frame: 3 months vs baseline, 6 months vs baseline, 9 months vs baseline, 12 months vs baseline, 3 months vs 6 months, 3 months vs 6 months, 3 months vs 9 months, and 3 months vs 12 months.
Change of probing attachment level (PAL)
Time frame: 3, 6, 9,12 months
Incidence of recurrent rate during experimental period.
Time frame: 3, 6, 9,12 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 2 Dec 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Periodontitis, run by National Dental Centre, Singapore.
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 7 inclusion and 6 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 2019. 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. 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?
Absolute change of probing pocket depth (PPD) (time frame: 3 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 2 Dec 2019.