Clinical trial NCT02972788: Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Official title: Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Periodontal Bone Loss
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Attachment Levels
timeFrame: 12 months
Secondary outcomes:
measure: Alveolar bone
timeFrame: 12 months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska Medical Center, College of Dentistry
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Amy Killeen, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: