Antibiotic Study for Dental Implants

Periodontitis Clinical Trial

Official title:

Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662532
• Other study ID #: OP-P-5265-1
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2008
• Last updated: December 6, 2011
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: December 2011
• Source: OraPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

Description:

At Visit 1, the dentist will:

• do an oral exam

• ask some questions

• decide if the person qualifies for being in the study

• make an appointment for Visit 2 if they qualify

At Visit 2 (Baseline), the dentist will:

• do a special cleaning of the implants

• examine the whole mouth

• collect some fluid

• take x-rays

• put the people into one of two groups (taking into account whether or not they smoke)

1. one group will have the study antibiotic put on all the areas in their mouth with gum problems

2. the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.

At Visit 4 (about 3 months later), the dentist will:

• collect fluid samples

• examine the whole mouth

• apply the antibiotic again for people in that group

At Visit 5 (about 6 months later), the dentist will:

• collect fluid samples

• examine the whole mouth

• take x-rays

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 21 years of age and good general health

• appropriately documented Informed Consent

• willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol

• female subjects must meet the pregnancy and contraceptive requirements

• must have oral health appropriate for study inclusion

Exclusion Criteria:

• oral health inappropriate for study inclusion

• females self-reporting pregnancy or lactation, or having a positive urine pregnancy result

• reporting any of the following conditions:

• allergy to a tetracycline-class drug

• systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures

• active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis

• diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement

• participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment

• employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator

• anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peri-Implantitis
• Periodontitis

Intervention

Drug:
• Minocycline HCl
1mg microspheres for professional subgingival administration into periodontal pockets two times throughout the duration of the trial

Locations

Country	Name	City	State
United States	JJCPPW Investigational Site	Ann Arbor	Michigan
United States	JJCPPW Investigational Site	Aurora	Colorado
United States	JJCPPW Investigational Site	Hazlet	New Jersey
United States	JJCPPW Investigational Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
OraPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall PD Reduction	Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject	Baseline to Day 180	No
Secondary	Initial PD Reduction	Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject	Baseline to Day 90	No
Secondary	BOP Percent Reduction From Baseline	Bleeding on Probing (BOP) percentage is calculated as the number of implant sites with bleeding divided by the number of implant sites per subject times 100% at each visit; reduction of BOP percentage is the BOP percentage at baseline minus the BOP percentage post-baseline	at Day 90 and Day 180	No