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

Periodontal Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972788
• Other study ID #: 0783-16-FB
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2017
• Est. completion date: September 20, 2018

Study information

• Verified date: November 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 20, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Periodontal Bone Loss

Intervention

Drug:
• Enamel Matrix Proteins Derivative
Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.

Other:
• Saline
Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, College of Dentistry	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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).	12 months