Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy

Periodontal Diseases Clinical Trial

— PERIOEMD-1  

Official title:

Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590093
• Other study ID #: 3649/13A
• Status: Completed
• Phase: N/A
• Start date: November 1, 2013
• 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 surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Good health

• No previous periodontal surgical treatment

• Indication for periodontal surgery (intrabony defects to be at least 4 mm deep)

• Ability to understand the study procedures and comply with them through the length of the study

Exclusion Criteria:

• Pregnancy, breast feeding or taking oral contraceptive (all non-drug contraceptives will be allowed)

• The need for antibiotic therapy to undergo periodontal therapy

• Chronic infections

• Systemic diseases

• Patients who report current smoking over 20 cigarettes per day or pipe or cigar

Related Conditions & MeSH terms

• Gingival Diseases
• Inflammation
• Periodontal Diseases

Intervention

Procedure:
• Periodontal surgery
After local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.
• EMD application
Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface

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	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	Cholesterol	analyzed though blood sampling. Unit of measure: mg/dL	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	Triglycerides	analyzed though blood sampling. Unit of measure: mg/dL	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	HDL Cholesterol	analyzed though blood sampling. Unit of measure: mg/dL	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	LDL Cholesterol	analyzed though blood sampling. Unit of measure: mg/dL	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	Fibrinogen	analyzed though blood sampling. Unit of measure: mg/dL	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	D-Dimer	analyzed though blood sampling. Unit of measure: mg/L	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	Cystatin C	analyzed though blood sampling. Unit of measure: mg/L	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	C Reactive Protein (CRP)	CRP analyzed though blood sampling. Unit of measure: mg/L	Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Secondary	Clinical attachment level (CAL) at deepest site	Changes in CAL , measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 6 months after treatment
Secondary	Pocket probing depth (PPD) at deepest site	Changes in PPD , measured orally through clinical examination. Unit of measure: mm	Measured at Baseline and 6 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 6 months after treatment