Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients (PERIOEMD-4)

University of Pisa

Status: Unknown

Conditions: Periodontal Diseases

Treatments: Device: Enamel Matrix Derivative application; Procedure: Root Instrumentation

Study type: Interventional

Funder types: Other

Identifiers

NCT04237662

3649-2019

Details and patient eligibility

About

The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of periodontal healing in diabetic patients.

Full description

Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm.

Metabolic glucose control as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with diabetes mellitus type II and currently under treatment;
• No previous periodontal treatment in the last 6 months;
• Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non- adjacent teeth);
• Ability to understand the study procedures and comply with them through the length of the study.

Exclusion criteria

• Pregnancy and breast feeding;
• Need for antibiotic treatment during periodontal therapy;
• Chronic infections;
• Systemic diseases;
• Patients who report current smoking over 20 cigarettes per day.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups

Test Group

Experimental group

Description:

Root Instrumentation + Enamel Matrix Derivative Application Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one- stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour. In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.

Treatment:

Procedure: Root Instrumentation

Device: Enamel Matrix Derivative application

Control Group

Active Comparator group

Description:

Root Instrumentation Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one- stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.

Treatment:

Procedure: Root Instrumentation