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Protocol Expired. Terminated by IRB
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This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and root planing | Procedure | Scaling and root planing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George A Macones, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20840689 | Derived | Jeffcoat M, Parry S, Sammel M, Clothier B, Catlin A, Macones G. Periodontal infection and preterm birth: successful periodontal therapy reduces the risk of preterm birth. BJOG. 2011 Jan;118(2):250-6. doi: 10.1111/j.1471-0528.2010.02713.x. Epub 2010 Sep 14. |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |