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Completed

NCT Number: NCT03544931

Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Pisa

Pisa, 56126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Root Instrumentation

Procedure

Instrumentation of the root surface in order to achieve debridement

EMD application

Device

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

Primary outcomes

  1. Change of C Reactive Protein (CRP) at 24 hour

    Time frame: Collected at Baseline and 24 hours in order to calculate the changes

    CRP analyzed though blood sampling. Unit of measure: mg/L

Secondary outcomes

  1. Glucose

    Time frame: Baseline, 24 hours and 3 months after treatment

    analyzed though blood sampling. Unit of measure: mg/dL

  2. Cholesterol

    Time frame: Collected at Baseline, 24 hours and 3 months after treatment

    analyzed though blood sampling. Unit of measure: mg/dL

  3. LDL Cholesterol

    Time frame: Collected at Baseline, 24 hours and 3 months after treatment

    analyzed though blood sampling. Unit of measure: mg/dL

  4. HDL Cholesterol

    Time frame: Collected at Baseline, 24 hours and 3 months after treatment

    analyzed though blood sampling. Unit of measure: mg/dL

  5. Triglyceride

    Time frame: Collected at Baseline, 24 hours and 3 months after treatment

    analyzed though blood sampling. Unit of measure: mg/dL

  6. Fibrinogen

    Time frame: Collected at Baseline, 24 hours and 3 months after treatment

    analyzed though blood sampling. Unit of measure: mg/dL

  7. D-Dimer

    Time frame: Collected at Baseline, 24 hours and 3 months after treatment

    analyzed though blood sampling. Unit of measure: mg/L

  8. Cystatin C

    Time frame: Collected at Baseline, 24 hours and 3 months after treatment

    analyzed though blood sampling. Unit of measure: mg/L

  9. Full-mouth plaque score (FMPS)

    Time frame: 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.

  10. Full-mouth bleeding score (FMBS)

    Time frame: 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.

  11. Pocket probing depth (PPD)

    Time frame: Measured at Baseline and 3 months after treatment

    Changes in PPD , measured orally through clinical examination. Unit of measure: mm

  12. Clinical attachment level (CAL)

    Time frame: Measured at Baseline and 3 months after treatment

    Changes in CAL , measured orally through clinical examination. Unit of measure: mm

  13. Recession of the gingival margin (REC)

    Time frame: Measured at Baseline and 3 months after treatment

    Changes in REC, measured orally through clinical examination. Unit of measure: mm

  14. Number of sites with Pocket probing depth deeper than 3mm

    Time frame: Measured at Baseline and 3 months after treatment

    Changes, measured orally through clinical examination. Unit of measure: N

  15. Number of sites with Pocket probing depth deeper than 5mm

    Time frame: Measured at Baseline and 3 months after treatment

    Changes, measured orally through clinical examination. Unit of measure: N

  16. Percentage of sites with Pocket probing depth deeper than 3mm

    Time frame: Measured at Baseline and 3 months after treatment

    Changes, measured orally through clinical examination. Unit of measure: %

  17. Percentage of sites with Pocket probing depth deeper than 5mm

    Time frame: Measured at Baseline and 3 months after treatment

    Changes, measured orally through clinical examination. Unit of measure: %

  18. Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline

    Time frame: Measured at Baseline and 3 months after treatment

    Changes , measured orally through clinical examination. Unit of measure: %

  19. Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline

    Time frame: Measured at Baseline and 3 months after treatment

    Changes , measured orally through clinical examination. Unit of measure: N

  20. C Reactive Protein (CRP) at 3 months

    Time frame: Collected 3 months after treatment

    CRP analyzed though blood sampling. Unit of measure: mg/L

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Collaborators

  • Institut Straumann AG

Registry information

Official study title

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

Acronym: PERIOEMD-2

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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