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| Name | Class |
|---|---|
| Academic Centre for Dentistry in Amsterdam | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| locally delivered minocycline | Active Comparator | Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minocycline | Drug | Periocline dental ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pocket Depth | PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuli Deng, Master | Affiliated Hospital of Stomatology, Medical College, Zhejiang University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surface and Root Planning | surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France) surface and root planning: surface and root planning |
| FG001 | Locally Delivered Minocycline | Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth minocycline: Periocline dental ointment surface and root planning: surface and root planning |
| FG002 | Surface and Root Planning+Minocycline | surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline. minocycline: Periocline dental ointment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surface and Root Planning | surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France) surface and root planning: surface and root planning |
| BG001 | Locally Delivered Minocycline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pocket Depth | PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter. | Posted | Mean | Standard Deviation | mm | 7 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surface and Root Planning | surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France) surface and root planning: surface and root planning |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ying Wang | Zhejiang University | 86-571-87217437 | wyi1006@sina.com |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| surface and root planning | Procedure | surface and root planning |
|
| 7 days |
Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth minocycline: Periocline dental ointment surface and root planning: surface and root planning |
| BG002 | Surface and Root Planning+Minocycline | surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline. minocycline: Periocline dental ointment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Surface and Root Planning+Minocycline | surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline. minocycline: Periocline dental ointment |
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | 7 days |
|
|
|
| Secondary | 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. | The analyzed units of the gene load of bacteria are log10. | Posted | Mean | Standard Deviation | log10 (copies/ml) | 7 days |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Locally Delivered Minocycline | Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth minocycline: Periocline dental ointment surface and root planning: surface and root planning | 0 | 26 | 0 | 26 |
| EG002 | Surface and Root Planning+Minocycline | surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline. minocycline: Periocline dental ointment | 0 | 23 | 0 | 23 |
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| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
|
| Porphyromonas gingivalis (Pg) |
|
| Prevotella intermedia (Pi) |
|