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Completed

NCT Number: NCT03590093

Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Pisa

Pisa, 56126, Italy

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 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

Treatment and study plan

Periodontal surgery

Procedure

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.

Other names: Open Flap Debridement

EMD application

Procedure

Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface

Other names: Amelogenins application

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: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  2. Cholesterol

    Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  3. Triglycerides

    Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  4. HDL Cholesterol

    Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  5. LDL Cholesterol

    Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  6. Fibrinogen

    Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  7. D-Dimer

    Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  8. Cystatin C

    Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  9. C Reactive Protein (CRP)

    Time frame: Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

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

  10. Clinical attachment level (CAL) at deepest site

    Time frame: Measured at Baseline and 6 months after treatment

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

  11. Pocket probing depth (PPD) at deepest site

    Time frame: Measured at Baseline and 6 months after treatment

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

  12. Recession of the gingival margin (REC)

    Time frame: Measured at Baseline and 6 months after treatment

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Collaborators

  • Institut Straumann AG

Registry information

Official study title

Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy

Acronym: PERIOEMD-1

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jul 18, 2018
Registry last updated
Jul 18, 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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