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The purpose of the study is to determine the effect of enamel matrix protein derivative on an inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix derivative protein with increase the clinical attachment level is localized sites of advanced periodontal disease.
The purpose of this study is to determine if local application of a commercially-available, FDA-approved preparation of enamel-matrix protein derivatives is effective in increasing clinical attachment levels (primary outcome), as well as alveolar bone (secondary outcome) compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT). Subjects will be divided into two groups for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of the enamel matrix protein derivate or 2) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of saline. Samples/measurements will be obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during PMT: 1) digital radiograph (baseline and 12 months only; bone height measurements), 2) presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid (GCF) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel junction, 5) probing pocket depth and bleeding on probing (BOP). Following the 12-month visit, the research-specific interventions and measurements in the experimental quadrant will be removed from routine PMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Group will receive enamel matrix protein derivative treatment along with scaling and root planing. |
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| Control Group | Sham Comparator | Group will receive placebo (saline) treatment along with scaling and root planing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enamel Matrix Proteins Derivative | Drug | Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Levels | This study is to determine if local application of a commercially-available, FDA-approved preparation of enamel-matrix protein derivatives is effective in increasing clinical attachment levels (periodontal tissue support) compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT). The following will be used in combination to evaluate impacts: digital radiograph (bone height), explorer-detectable supragingival plaque, 30-second GCF sample (markers of inflammation and bone turnover), recession, probing pocket depth (measurement of clinical attachment loss), and bleeding on probing (BoP). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar bone | This study is to determine if local application of a commercially-available, FDA-approved preparation of enamel-matrix protein derivatives is effective in increasing alveolar bone compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT). The following will be used in combination to evaluate impacts: digital radiograph (bone height), explorer-detectable supragingival plaque, 30-second GCF sample (markers of inflammation and bone turnover), recession, probing pocket depth (measurement of clinical attachment loss), and bleeding on probing (BoP). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Killeen, DDS, MS | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center, College of Dentistry | Lincoln | Nebraska | 68503 | United States |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| C109069 | enamel matrix proteins |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Saline | Other | Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy. |
|
| 12 months |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D017670 |
| Sodium Compounds |