NCT02355977

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 2, 2015

Completed
Last Updated

December 2, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

January 31, 2015

Results QC Date

September 26, 2015

Last Update Submit

October 29, 2015

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitisMinocyclineSurface and root planningPocket depthSulcus bleeding indexPrevotella intermedia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Bleeding on Probing

    7 days

  • Bacterial Load

    7 days

Study Arms (3)

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)

Procedure: surface and root planning

locally delivered minocycline

ACTIVE COMPARATOR

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

Drug: minocyclineProcedure: surface and root planning

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.

Drug: minocycline

Interventions

minocyclineDRUG

Periocline dental ointment

Also known as: Periocline dental ointment
locally delivered minocyclinesurface and root planning+minocycline
surface and root planningPROCEDURE

surface and root planning

locally delivered minocyclinesurface and root planning

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitiscyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Dr. Ying Wang
Organization
Zhejiang University
wyi1006@sina.com
86-571-87217437

Study Officials

  • Shuli Deng, Master

    Affiliated Hospital of Stomatology, Medical College, Zhejiang University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 4, 2015

Study Start

June 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

December 2, 2015

Results First Posted

December 2, 2015

Record last verified: 2015-10