The Impact of Enamel Matrix Derivatives on Periodontal Healing in Diabetic Patients After Non-Surgical Periodontal Therapy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Pisa
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Pocket probing depth (PPD)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
Opaque envelopes
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Root Instrumentation (Procedure)
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.
Intervention: Root Instrumentation (Procedure)
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.
Intervention: Enamel Matrix Derivative application (Device)
Outcomes
Primary Outcomes
Pocket probing depth (PPD)
Time Frame: Measured at Baseline and 3 months after treatment
Changes in PPD, measured orally through clinical examination. Unit of measure: mm
Secondary Outcomes
- Number of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
- Full-mouth plaque score (FMPS)(Measured at Baseline and 3 months after treatment)
- Oxford Happiness Questionnaire (OHQ)(Measured at Baseline and 3 months after treatment)
- Glycated Hemoglobin (HbA1c)(Measured at Baseline and 3 months after treatment)
- Clinical attachment level (CAL)(Measured at Baseline and 3 months after treatment)
- Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline(Measured at Baseline and 3 months after treatment)
- Oral Health Index Profile-14 (OHIP-14)(Measured at Baseline and 3 months after treatment)
- High sensitivity C-Reactive Protein (hsCRP)(Measured at Baseline and 3 months after treatment)
- Recession of the gingival margin (REC)(Measured at Baseline and 3 months after treatment)
- Percentage of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
- Full-mouth bleeding score (FMBS)(Measured at Baseline and 3 months after treatment)
Investigators
Filippo Graziani, DDS MClinDent PhD
Full Professor
University of Pisa