Clinical trial NCT03590093: Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy
Official title: Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University of Pisa
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2018-07-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of C Reactive Protein (CRP) at 24 hour
timeFrame: Collected at Baseline and 24 hours in order to calculate the changes
Secondary outcomes:
measure: Glucose
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: Cholesterol
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: Triglycerides
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: HDL Cholesterol
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: LDL Cholesterol
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: Fibrinogen
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: D-Dimer
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: Cystatin C
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: C Reactive Protein (CRP)
timeFrame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
measure: Clinical attachment level (CAL) at deepest site
timeFrame: Measured at Baseline and 6 months after treatment
measure: Pocket probing depth (PPD) at deepest site
timeFrame: Measured at Baseline and 6 months after treatment
measure: Recession of the gingival margin (REC)
timeFrame: Measured at Baseline and 6 months after treatment
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University Hospital of Pisa
Study officials:
References:
citation: Graziani F, Peric M, Marhl U, Petrini M, Bettini L, Tonetti M, Gennai S. Local application of enamel matrix derivative prevents acute systemic inflammation after periodontal regenerative surgery: A randomized controlled clinical trial. J Clin Periodontol. 2020 Jun;47(6):747-755. doi: 10.1111/jcpe.13270. Epub 2020 Mar 12.