An Early Phase 1 interventional study of Enamel Matrix Proteins Derivative and Saline in Periodontal Bone Loss, sponsored by University of Nebraska. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by University of Nebraska · Early Phase 1, Interventional, and Treatment
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.
304 studies on the registry are indexed under Alveolar Bone Loss; 77 are open to participants now.
This study's enrollment of 50 is above the median of 25 across 261 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
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Exclusion Criteria:
Group will receive enamel matrix protein derivative treatment along with scaling and root planing.
Drug: Enamel Matrix Proteins Derivative
Group will receive placebo (saline) treatment along with scaling and root planing.
Other: Saline
Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
Also known as: Emdogain
Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
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).
Time frame: 12 months
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).
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enamel matrix proteins