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Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunstar Americas
ClinicalTrials.gov Identifier:
NCT00529555
First received: September 11, 2007
Last updated: April 10, 2014
Last verified: April 2014
Results First Received: July 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Adult Periodontitis
Interventions: Drug: minocycline HCl 2.1%
Procedure: Scaling and root planing

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Scaling and Root Planing + SHAM TX Empty syringe + Scaling and root planing
Scaling & Root Planing + Periocline Gel

Gel WITH Minocycline HCL 2.1% + Scaling & root planing

minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.

Scaling and Root Planing + Vehicle Gel WITHOUT 2.1% Minocycline HCl + Scaling and root planing

Participant Flow:   Overall Study
    Scaling and Root Planing + SHAM TX     Scaling & Root Planing + Periocline Gel     Scaling and Root Planing + Vehicle  
STARTED     200     202     200  
COMPLETED     171     172     174  
NOT COMPLETED     29     30     26  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Scaling and Root Planing + SHAM TX

sham treatment

Scaling and root planing : scaling and root planing

Scaling & Root Planing + Periocline Gel

Minocycline HCL 2.1%

minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.

Scaling and Root Planing + Vehicle

Placebo

Scaling and root planing : scaling and root planing

Total Total of all reporting groups

Baseline Measures
    Scaling and Root Planing + SHAM TX     Scaling & Root Planing + Periocline Gel     Scaling and Root Planing + Vehicle     Total  
Number of Participants  
[units: participants]
  200     202     200     602  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     193     196     198     587  
>=65 years     7     6     2     15  
Age  
[units: years]
Mean ± Standard Deviation
  49.8  ± 11.5     49.2  ± 11.8     50.2  ± 12.0     49.7  ± 11.8  
Gender  
[units: participants]
       
Female     99     108     93     300  
Male     101     94     107     302  
Region of Enrollment  
[units: participants]
       
United States     200     202     200     602  



  Outcome Measures

1.  Primary:   Change in Pocket Depth.   [ Time Frame: baseline & 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Marie Wilson, Clinical Program Manager
Organization: Sunstar Americas, Inc
phone: 773-481-3327
e-mail: marie.wilson@us.sunstar.com


No publications provided


Responsible Party: Sunstar Americas
ClinicalTrials.gov Identifier: NCT00529555     History of Changes
Other Study ID Numbers: SB-PER-05-001
Study First Received: September 11, 2007
Results First Received: July 10, 2013
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration