Clinical trial NCT03544931: Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy
Official title: The Impact of Enamel Matrix Derivatives on Markers of Systemic Inflammation After Flapless Periodontal 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: 2018-06-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 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.

Eligibility criteria: 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

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: Baseline, 24 hours and 3 months after treatment
measure: Cholesterol
timeFrame: Collected at Baseline, 24 hours and 3 months after treatment
measure: LDL Cholesterol
timeFrame: Collected at Baseline, 24 hours and 3 months after treatment
measure: HDL Cholesterol
timeFrame: Collected at Baseline, 24 hours and 3 months after treatment
measure: Triglyceride
timeFrame: Collected at Baseline, 24 hours and 3 months after treatment
measure: Fibrinogen
timeFrame: Collected at Baseline, 24 hours and 3 months after treatment
measure: D-Dimer
timeFrame: Collected at Baseline, 24 hours and 3 months after treatment
measure: Cystatin C
timeFrame: Collected at Baseline, 24 hours and 3 months after treatment
measure: Full-mouth plaque score (FMPS)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Full-mouth bleeding score (FMBS)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Pocket probing depth (PPD)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Clinical attachment level (CAL)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Recession of the gingival margin (REC)
timeFrame: Measured at Baseline and 3 months after treatment
measure: Number of sites with Pocket probing depth deeper than 3mm
timeFrame: Measured at Baseline and 3 months after treatment
measure: Number of sites with Pocket probing depth deeper than 5mm
timeFrame: Measured at Baseline and 3 months after treatment
measure: Percentage of sites with Pocket probing depth deeper than 3mm
timeFrame: Measured at Baseline and 3 months after treatment
measure: Percentage of sites with Pocket probing depth deeper than 5mm
timeFrame: Measured at Baseline and 3 months after treatment
measure: Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
timeFrame: Measured at Baseline and 3 months after treatment
measure: Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
timeFrame: Measured at Baseline and 3 months after treatment
measure: C Reactive Protein (CRP) at 3 months
timeFrame: Collected 3 months after treatment
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University Hospital of Pisa
Study officials:
References:
citation: Graziani F, Gennai S, Petrini M, Bettini L, Tonetti M. Enamel matrix derivative stabilizes blood clot and improves clinical healing in deep pockets after flapless periodontal therapy: A Randomized Clinical Trial. J Clin Periodontol. 2019 Feb;46(2):231-240. doi: 10.1111/jcpe.13074.