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Clinical trial

Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients

ID
Name
0783-16-FB
Description
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.
Trial arms
Trial start
2017-02-01
Estimated PCD
2018-09-20
Trial end
2018-09-20
Status
Completed
Phase
Early phase I
Treatment
Enamel Matrix Proteins Derivative
Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
Arms:
Experimental Group
Other names:
Emdogain
Saline
Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
Arms:
Control Group
Size
50
Primary endpoint
Clinical Attachment Levels
12 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-12-01

1 organization

1 product

1 indication

Organization
University of Nebraska
Product
Enamel Matrix Proteins
Indication
Periodontal Bone Loss