Enamel Matrix Derivatives & Periodontal Therapy in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Periodontal Diseases

Intervention / Treatment
-----------------
* Procedure: Root Instrumentation
* Device: Enamel Matrix Derivative application


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-centre randomized, parallel design, clinical trial with a 3-month follow-up
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>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<br>* Instrumentation of the root surface in order to achieve debridement<br>Device: Enamel Matrix Derivative application<br>* Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths<br>|
| Active Comparator: Control Group<br>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<br>* Instrumentation of the root surface in order to achieve debridement<br>|

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 |