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

The Impact of Enamel Matrix Derivatives on Periodontal Healing in Diabetic Patients After Non-Surgical Periodontal Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Root Instrumentation; Device: Enamel Matrix Derivative application

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56121
    • Recruiting
    • University Hospital of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; 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.	Procedure: Root Instrumentation; Instrumentation of the root surface in order to achieve debridement; Device: Enamel Matrix Derivative application; Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths
Active Comparator: Control Group; 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.	Procedure: Root Instrumentation; Instrumentation of the root surface in order to achieve debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket probing depth (PPD)	Changes in PPD, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	Changes in CAL, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 3 months after treatment
Recession of the gingival margin (REC)	Changes in REC, measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 3 months after treatment
Number of sites with Pocket probing depth deeper than 5mm	Changes, measured orally through clinical examination. Unit of measure: N	Measured at Baseline and 3 months after treatment
Percentage of sites with Pocket probing depth deeper than 5mm	Changes, measured orally through clinical examination. Unit of measure: %	Measured at Baseline and 3 months after treatment
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline	Changes, measured orally through clinical examination. Unit of measure: %	Measured at Baseline and 3 months after treatment
Full-mouth plaque score (FMPS)	Changes in Full-mouth plaque score, measuring the amount of dental plaque on the teeth orally through clinical examination. Unit of measure %. The scale ranges from 0% (minimum value, i.e. plaque absent) to 100% (maximum value: all areas are occupied by plaque). 0% would the ideal value. No sub-scales are included.	Measured at Baseline and 3 months after treatment
Full-mouth bleeding score (FMBS)	Changes of Full-mouth bleeding score, measuring the number of gingival areas that bleed after gingival probe passage. It is measured oral through clinical examination. Unit of measure %. The scale ranges from 0% (minimum value, i. e. gingival inflammation is absent) to 100% (maximum value: all gingival areas are inflamed). 0% would be the ideal value. No sub-scales are included.	Measured at Baseline and 3 months after treatment
Oral Health Index Profile-14 (OHIP-14)	Changes in Oral Health Index Profile-14 measured through administration of specific questionnaire . Responses for the questionnaire are made on a Likert-type five-point scale, coded 0 (never), 1 (hardly ever), 2 (occasionally), 3 (fairly often), and 4 (very often); with scores ranging from 0-56 and higher scores indicating worse	Measured at Baseline and 3 months after treatment
Oxford Happiness Questionnaire (OHQ)	Responses for the questionnaire are made on a Likert scale, coded from strongly disagree = 1 to strongly agree = 6, with the higher scores corresponding to higher levels of happiness. For the 12 negatively worded items, the reverse coding is necessary before calculating the total score, which is a sum of individual item scores. Score range is from 1 as a minimum and 6 as a maximum score.	Measured at Baseline and 3 months after treatment
High sensitivity C-Reactive Protein (hsCRP)	analyzed through blood sampling. Unit of measure: mg/L	Measured at Baseline and 3 months after treatment
Glycated Hemoglobin (HbA1c)	analyzed through blood sampling. Unit of measure: mmol/mol	Measured at Baseline and 3 months after treatment

Collaborators and Investigators

• Sponsor: University of Pisa

Publications and helpful links

General Publications

• Graziani F, Gennai S, Petrini M, Bettini L, Tonetti M. Enamel matrix derivative stabilizes blood clot and improves clinical healing in deep pockets after flapless periodontal therapy: A Randomized Clinical Trial. J Clin Periodontol. 2019 Feb;46(2):231-240. doi: 10.1111/jcpe.13074.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 3649-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No