Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy (PERIOEMD-1)

University of Pisa

Status: Completed

Conditions: Periodontal Diseases

Treatments: Procedure: EMD application; Procedure: Periodontal surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03590093

3649/13A

Details and patient eligibility

About

The aim of this study is to compare surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Good health
• No previous periodontal surgical treatment
• Indication for periodontal surgery (intrabony defects to be at least 4 mm deep)
• Ability to understand the study procedures and comply with them through the length of the study

Exclusion criteria

• Pregnancy, breast feeding or taking oral contraceptive (all non-drug contraceptives will be allowed)
• The need for antibiotic therapy to undergo periodontal therapy
• Chronic infections
• Systemic diseases
• Patients who report current smoking over 20 cigarettes per day or pipe or cigar

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Periodontal Surgery with EMD

Experimental group

Description:

A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. After carefully cleaning root dental surfaces, EMD was placed inside the infrabony periodontal defect. Suture were placed to maintain wound stability.

Treatment:

Procedure: EMD application

Procedure: Periodontal surgery

Periodontal Surgery

Active Comparator group

Description:

A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability.

Treatment:

Procedure: Periodontal surgery