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

Early Phase 1

Completed

• Conditions: Periodontal Bone Loss
• Interventions: Other: Saline; Drug: Enamel Matrix Proteins Derivative

• Registration Number: NCT02972788
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-23
• Study Start: 2017-02-01
• Primary Completion: 2018-09-20
• Study Completion: 2018-09-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Saline	Group will receive placebo (saline) treatment along with scaling and root planing.
Experimental Group	Enamel Matrix Proteins Derivative	Group will receive enamel matrix protein derivative treatment along with scaling and root planing.

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Levels	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Alveolar bone	12 months	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).

Trial Locations

Locations (1)

University of Nebraska Medical Center, College of Dentistry; 🇺🇸 Lincoln, Nebraska, United States