Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

Periodontal Diseases Clinical Trial

— PERIOEMD-2  

Official title:

The Impact of Enamel Matrix Derivatives on Markers of Systemic Inflammation After Flapless Periodontal Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544931
• Other study ID #: 3649/15B
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2018
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of acute-phase responses in healthy patients.

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.

Systemic inflammation as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Good health

• No previous periodontal treatment

• 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

Related Conditions & MeSH terms

• Gingival Diseases
• Inflammation
• Periodontal Diseases

Intervention

Procedure:
• Root Instrumentation
Instrumentation of the root surface in order to achieve debridement

Device:
• EMD Application
Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm

Locations

Country	Name	City	State
Italy	University Hospital of Pisa	Pisa

Sponsors (2)

Lead Sponsor	Collaborator
University of Pisa	Institut Straumann AG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of C Reactive Protein (CRP) at 24 hour	CRP analyzed though blood sampling. Unit of measure: mg/L	Collected at Baseline and 24 hours in order to calculate the changes
Secondary	Glucose	analyzed though blood sampling. Unit of measure: mg/dL	Baseline, 24 hours and 3 months after treatment
Secondary	Cholesterol	analyzed though blood sampling. Unit of measure: mg/dL	Collected at Baseline, 24 hours and 3 months after treatment
Secondary	LDL Cholesterol	analyzed though blood sampling. Unit of measure: mg/dL	Collected at Baseline, 24 hours and 3 months after treatment
Secondary	HDL Cholesterol	analyzed though blood sampling. Unit of measure: mg/dL	Collected at Baseline, 24 hours and 3 months after treatment
Secondary	Triglyceride	analyzed though blood sampling. Unit of measure: mg/dL	Collected at Baseline, 24 hours and 3 months after treatment
Secondary	Fibrinogen	analyzed though blood sampling. Unit of measure: mg/dL	Collected at Baseline, 24 hours and 3 months after treatment
Secondary	D-Dimer	analyzed though blood sampling. Unit of measure: mg/L	Collected at Baseline, 24 hours and 3 months after treatment
Secondary	Cystatin C	analyzed though blood sampling. Unit of measure: mg/L	Collected at Baseline, 24 hours and 3 months after treatment
Secondary	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
Secondary	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 orally 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 the ideal value. No sub-scales are included.	Measured at Baseline and 3 months after treatment
Secondary	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	Clinical attachment level (CAL)	Changes in CAL , measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 3 months after treatment
Secondary	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
Secondary	Number of sites with Pocket probing depth deeper than 3mm	Changes, measured orally through clinical examination. Unit of measure: N	Measured at Baseline and 3 months after treatment
Secondary	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
Secondary	Percentage of sites with Pocket probing depth deeper than 3mm	Changes, measured orally through clinical examination. Unit of measure: %	Measured at Baseline and 3 months after treatment
Secondary	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
Secondary	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
Secondary	Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline	Changes , measured orally through clinical examination. Unit of measure: N	Measured at Baseline and 3 months after treatment
Secondary	C Reactive Protein (CRP) at 3 months	CRP analyzed though blood sampling. Unit of measure: mg/L	Collected 3 months after treatment