Chronic Periodontitis
Conditions
Keywords
Chronic periodontitis, Minocycline, Surface and root planning, Pocket depth, Sulcus bleeding index, Prevotella intermedia
Brief 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.
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.
Interventions
DRUGminocycline
Periocline dental ointment
PROCEDUREsurface and root planning
surface and root planning
Sponsors
Academic Centre for Dentistry in Amsterdam
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pocket Depth | 7 days | PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on Probing | 7 days | 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) |
| Bacterial Load | 7 days | Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| 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 | 26 |
| 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 | 23 |
| Total | 70 |
Baseline characteristics
| Characteristic | Surface and Root Planning | Locally Delivered Minocycline | Surface and Root Planning+Minocycline | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 22 Participants | 22 Participants | 64 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 15 | 50 years STANDARD_DEVIATION 13 | 49 years STANDARD_DEVIATION 11 | 49 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 26 Participants | 23 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 21 participants | 26 participants | 23 participants | 70 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 12 Participants | 34 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 11 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 26 | 0 / 23 |
| serious Total, serious adverse events | 0 / 21 | 0 / 26 | 0 / 23 |
Outcome results
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surface and Root Planning | Pocket Depth | 4.34 mm | Standard Deviation 0.57 |
| Locally Delivered Minocycline | Pocket Depth | 4.81 mm | Standard Deviation 0.99 |
| Surface and Root Planning+Minocycline | Pocket Depth | 4.5 mm | Standard Deviation 0.53 |
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.
Time frame: 7 days
Population: The analyzed units of the gene load of bacteria are log10.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Surface and Root Planning | Bacterial Load | Aggregatibacter actinomycetemcomitans (Aa) | 5.55 log10 (copies/ml) | Standard Deviation 0.59 |
| Surface and Root Planning | Bacterial Load | Fusobacterium nucleatum (Fn) | 6.77 log10 (copies/ml) | Standard Deviation 0.39 |
| Surface and Root Planning | Bacterial Load | Porphyromonas gingivalis (Pg) | 7.11 log10 (copies/ml) | Standard Deviation 1.77 |
| Surface and Root Planning | Bacterial Load | Prevotella intermedia (Pi) | 4.98 log10 (copies/ml) | Standard Deviation 0.72 |
| Locally Delivered Minocycline | Bacterial Load | Prevotella intermedia (Pi) | 4.58 log10 (copies/ml) | Standard Deviation 1.16 |
| Locally Delivered Minocycline | Bacterial Load | Aggregatibacter actinomycetemcomitans (Aa) | 4.32 log10 (copies/ml) | Standard Deviation 1.67 |
| Locally Delivered Minocycline | Bacterial Load | Porphyromonas gingivalis (Pg) | 6.72 log10 (copies/ml) | Standard Deviation 1.73 |
| Locally Delivered Minocycline | Bacterial Load | Fusobacterium nucleatum (Fn) | 6.37 log10 (copies/ml) | Standard Deviation 0.43 |
| Surface and Root Planning+Minocycline | Bacterial Load | Prevotella intermedia (Pi) | 4.77 log10 (copies/ml) | Standard Deviation 0.92 |
| Surface and Root Planning+Minocycline | Bacterial Load | Fusobacterium nucleatum (Fn) | 6.72 log10 (copies/ml) | Standard Deviation 0.42 |
| Surface and Root Planning+Minocycline | Bacterial Load | Porphyromonas gingivalis (Pg) | 7.13 log10 (copies/ml) | Standard Deviation 1.78 |
| Surface and Root Planning+Minocycline | Bacterial Load | Aggregatibacter actinomycetemcomitans (Aa) | 4.77 log10 (copies/ml) | Standard Deviation 0.86 |
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)
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surface and Root Planning | Bleeding on Probing | 1.42 units on a scale | Standard Deviation 0.55 |
| Locally Delivered Minocycline | Bleeding on Probing | 1.23 units on a scale | Standard Deviation 0.7 |
| Surface and Root Planning+Minocycline | Bleeding on Probing | 1.42 units on a scale | Standard Deviation 0.55 |