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

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    University of Pisa
Updated on 24 February 2022
type 2 diabetes mellitus
periodontal treatment


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.


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.

Condition Periodontal Diseases
Treatment Root Instrumentation, Enamel Matrix Derivative application
Clinical Study IdentifierNCT04237662
SponsorUniversity of Pisa
Last Modified on24 February 2022


Yes No Not Sure

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 nonadjacent 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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