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The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis

NCT ID: NCT02355977

Last Updated: 2015-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

surface and root planning

Intervention Type PROCEDURE

surface and root planning

locally delivered minocycline

Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth

Group Type ACTIVE_COMPARATOR

minocycline

Intervention Type DRUG

Periocline dental ointment

surface and root planning

Intervention Type PROCEDURE

surface and root planning

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.

Group Type EXPERIMENTAL

minocycline

Intervention Type DRUG

Periocline dental ointment

Interventions

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minocycline

Periocline dental ointment

Intervention Type DRUG

surface and root planning

surface and root planning

Intervention Type PROCEDURE

Other Intervention Names

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Periocline dental ointment

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academic Centre for Dentistry in Amsterdam

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Shuli Deng

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuli Deng, Master

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Stomatology, Medical College, Zhejiang University

Other Identifiers

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2013-25

Identifier Type: -

Identifier Source: org_study_id