Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Status: | Completed |
---|---|
Conditions: | Dental |
Therapuetic Areas: | Dental / Maxillofacial Surgery |
Healthy: | No |
Age Range: | Any |
Updated: | 11/16/2018 |
Start Date: | February 1, 2017 |
End Date: | September 20, 2018 |
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.
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.
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.
Inclusion Criteria:
- diagnosis of chronic advanced adult periodontitis
- one quadrant with at least one 6-9 mm interproximal pocket
- overall good systemic health
- willingness to sign consent form
Exclusion Criteria:
- systemic diseases which significantly impact periodontal inflammation and bone
turnover (e.g. rheumatoid arthritis)
- taking drugs which significantly impact periodontal inflammation and bone turnover
- surgical periodontal therapy within the past year
- pregnant or breast-feeding females
We found this trial at
1
site
4000 East Campus Loop
Lincoln, Nebraska 68583
Lincoln, Nebraska 68583
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