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| ID | Type | Description | Link |
|---|---|---|---|
| NIDCR-DE014338 | Other Identifier | NIDCR |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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The purpose of this study is to determine if non-surgical periodontal (gum) treatment can reduce the incidence of preterm birth and low birth weight babies in mothers with periodontitis (gum disease).
Eight hundred sixteen women who are between 13 and 16 weeks pregnant will be enrolled in this trial. Volunteers will be recruited from Hennepin County Medical Center (MN), the Jackson Medical Mall (MS), the University of Kentucky, and Harlem (NY) Hospital. The incidence of preterm birth is higher at these sites than the national average. Subjects will be randomly assigned to receive non-surgical mechanical periodontal therapy (scaling and root planing) either prior to 20 weeks of their pregnancy or soon after delivery. All subjects will be monitored for progressive periodontitis and will be treated immediately regardless of their group assignment. All women will also receive essential dental care to restore caries and treat abscessed teeth. The primary birth outcome is gestational age at birth and the secondary outcome is birthweight. Maternal risk factors for preterm birth and/or intrauterine growth restriction will be used as covariates in the data analysis. The study will also document the effect of periodontal therapy on immune response, systemic markers of inflammation, periodontal infection and clinical periodontal measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and root planing | Active Comparator | Scaling and root planing delivered prior to 21 weeks of gestation. |
|
| Placebo | No Intervention | Delayed treatment group. Controls monitored clinically from baseline to 29-32 weeks of gestation. Scaling and root planing provided after delivery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal scaling and root planing | Procedure | Hard and soft tisse deposits (plaque and calculus) are removed from the tooth and tooth root using hand and ultrasonic instruments. |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at birth | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Infant birth weight | At delivery | |
| Periodontal probing depth | 29-32 weeks of gestation | |
| Clinical attachment loss |
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Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerisity of Minnesota School Of Dentistry | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17079762 | Result | Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, Buchanan W, Bofill J, Papapanou PN, Mitchell DA, Matseoane S, Tschida PA; OPT Study. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med. 2006 Nov 2;355(18):1885-94. doi: 10.1056/NEJMoa062249. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| D016745 | Root Planing |
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
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| Scaling and root planing | Procedure | Delivered using hand and powered scalers and with topical or local (injected) anesthetics as needed. Procedures performed over 1 to 4 90-minute visits. |
|
| 29-32 weeks of gestation |
| Bleeding following periodontal probing | 29-32 weeks |
| D007744 |
| Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D013357 |
| Subgingival Curettage |
| D011313 | Preventive Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |