Obstetrics and Periodontal Therapy (OPT) Study (OPT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00066131|
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : July 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis Infant, Premature||Procedure: Periodontal scaling and root planing Procedure: Scaling and root planing||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||823 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Periodontal Therapy on Preterm Birth|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||February 2006|
Active Comparator: Scaling and root planing
Scaling and root planing delivered prior to 21 weeks of gestation.
Procedure: Periodontal scaling and root planing
Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments.
Other Name: Deep cleaning
Procedure: Scaling and root planing
Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits.
No Intervention: Placebo
Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery.
- Gestational age at birth [ Time Frame: At delivery ]
- Infant birth weight [ Time Frame: At delivery ]
- Periodontal probing depth [ Time Frame: 29-32 weeks of gestation ]
- Clinical attachment loss [ Time Frame: 29-32 weeks of gestation ]
- Bleeding following periodontal probing [ Time Frame: 29-32 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066131
|United States, Minnesota|
|Univerisity of Minnesota School Of Dentistry|
|Minneapolis, Minnesota, United States, 55455|
|Study Director:||Panos Papapanou, DDS, PhD||Harlem Hospital|
|Study Director:||Anthony DiAngelis, DMD||Hennepin County Medical Center, Minneapolis|
|Study Director:||William Buchanan, DDS||Jackson Medical Mall|
|Study Director:||John Novak, DDS||University of Kentucky|