Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

Not Applicable

Completed

• Conditions: Periodontal Diseases

• Registration Number: NCT03544931
• Lead Sponsor: University of Pisa

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 acute-phase responses in healthy 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.

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

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2018-01-01
• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-05-31
• Study Completion: 2018-06-01
• Study First Posted: 2018-06-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of C Reactive Protein (CRP) at 24 hour	Collected at Baseline and 24 hours in order to calculate the changes	CRP analyzed though blood sampling. Unit of measure: mg/L

Secondary Outcome Measures

Name	Time	Method
Fibrinogen	Collected at Baseline, 24 hours and 3 months after treatment	analyzed though blood sampling. Unit of measure: mg/dL
LDL Cholesterol	Collected at Baseline, 24 hours and 3 months after treatment	analyzed though blood sampling. Unit of measure: mg/dL
HDL Cholesterol	Collected at Baseline, 24 hours and 3 months after treatment	analyzed though blood sampling. Unit of measure: mg/dL
D-Dimer	Collected at Baseline, 24 hours and 3 months after treatment	analyzed though blood sampling. Unit of measure: mg/L
Clinical attachment level (CAL)	Measured at Baseline and 3 months after treatment	Changes in CAL , measured orally through clinical examination. Unit of measure: mm
Percentage of sites with Pocket probing depth deeper than 3mm	Measured at Baseline and 3 months after treatment	Changes, measured orally through clinical examination. Unit of measure: %
Cystatin C	Collected at Baseline, 24 hours and 3 months after treatment	analyzed though blood sampling. Unit of measure: mg/L
Number of sites with Pocket probing depth deeper than 3mm	Measured at Baseline and 3 months after treatment	Changes, measured orally through clinical examination. Unit of measure: N
Cholesterol	Collected at Baseline, 24 hours and 3 months after treatment	analyzed though blood sampling. Unit of measure: mg/dL
Triglyceride	Collected at Baseline, 24 hours and 3 months after treatment	analyzed though blood sampling. Unit of measure: mg/dL
Full-mouth plaque score (FMPS)	Measured at Baseline and 3 months after treatment	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.
Recession of the gingival margin (REC)	Measured at Baseline and 3 months after treatment	Changes in REC, measured orally through clinical examination. Unit of measure: mm
Glucose	Baseline, 24 hours and 3 months after treatment	analyzed though blood sampling. Unit of measure: mg/dL
Full-mouth bleeding score (FMBS)	Measured at Baseline and 3 months after treatment	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.
Number of sites with Pocket probing depth deeper than 5mm	Measured at Baseline and 3 months after treatment	Changes, measured orally through clinical examination. Unit of measure: N
Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline	Measured at Baseline and 3 months after treatment	Changes , measured orally through clinical examination. Unit of measure: N
Percentage of sites with Pocket probing depth deeper than 5mm	Measured at Baseline and 3 months after treatment	Changes, measured orally through clinical examination. Unit of measure: %
Pocket probing depth (PPD)	Measured at Baseline and 3 months after treatment	Changes in PPD , measured orally through clinical examination. Unit of measure: mm
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline	Measured at Baseline and 3 months after treatment	Changes , measured orally through clinical examination. Unit of measure: %
C Reactive Protein (CRP) at 3 months	Collected 3 months after treatment	CRP analyzed though blood sampling. Unit of measure: mg/L

Trial Locations

Locations (1)

University Hospital of Pisa; 🇮🇹 Pisa, Italy