Antibiotic Study for Dental Implants

This study has been completed.

Study NCT00662532 Information provided by OraPharma

First Received on April 17, 2008. Last Updated on December 6, 2011 History of Changes

Results First Received: April 27, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Periodontitis
Intervention:	Drug: Minocycline HCl

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Minocycline HCl	1 mg microspheres of minocycline hydrochloride
No Intervention	Control group receiving no drug intervention

Participant Flow: Overall Study

	Minocycline HCl	No Intervention
STARTED	22	22
COMPLETED	22	20
NOT COMPLETED	0	2
Adverse Event	0	1
Lost to Follow-up	0	1

Baseline Characteristics

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Reporting Groups

	Description
Minocycline HCl	1 mg microspheres of minocycline hydrochloride
No Intervention	Control group receiving no drug intervention

Baseline Measures

	Minocycline HCl	No Intervention	Total
Number of Participants [units: participants]	22	22	44
Age [units: years] Mean ± Standard Deviation	67.59 ± 12.37	66.05 ± 10.97	66.82 ± 11.58
Gender [units: participants]
Female	10	11	21
Male	12	11	23
Region of Enrollment [units: participants]
United States	22	22	44

Outcome Measures

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1. Primary:

Overall PD Reduction [ Time Frame: Baseline to Day 180 ]

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2. Secondary:

Initial PD Reduction [ Time Frame: Baseline to Day 90 ]

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3. Secondary:

BOP Percent Reduction From Baseline [ Time Frame: at Day 90 and Day 180 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Ms. Bindu Patel, Senior Scientist, Regulatory Affairs and Quality Assurance
Organization: OraPharma
phone: 215-420-4064
e-mail: bpatel@orapharma.com

No publications provided

Responsible Party:	OraPharma
ClinicalTrials.gov Identifier:	NCT00662532 History of Changes
Other Study ID Numbers:	OP-P-5265-1
Study First Received:	April 17, 2008
Results First Received:	April 27, 2010
Last Updated:	December 6, 2011
Health Authority:	United States: Food and Drug Administration