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Completed

NCT Number: NCT04449393

Enamel Matrix Derivative in Non-surgical Periodontal Treatment

The aim of the study is to investigate the effect of enamel matrix derivative in addition to scaling and root planing in comparison to scaling and root planing only in periodontitis patients that have already undergone initial periodontal therapy and are in periodontal maintenance.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic of Dentistry Vienna

Vienna, 1090, Austria

About this study

Enamel matrix derivative (EMD) have already been widely applied as a regenerative bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal regeneration. Recently, also its flapless, non-surgical application has been shown to have beneficial effects when applied during initial therapy of periodontitis.

The present study is designed as a single-blinded randomized controlled clinical trial. We plan to include a total of 50 periodontitis patients that have already undergone initial periodontal therapy, but still show remaining sites with increased periodontal probing depth (PPD). Patients will be randomly allocated at a 1:1 ratio to either scaling and root planing (SRP) in combination with EMD application into the affected pockets (test group, n=25) or to SRP only (control group, n=25). Before treatment, as well as after 3, 6 and 12 months, we plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene indices. Furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters representing periodontal disease activity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Periodontitis stage III
  • Patients that have completed initial periodontal therapy, and have remaining periodontal pockets of ≥6mm up to 9mm PPD
  • Given written informed consent form for participation in the study

Exclusion criteria

  • Systemic antibiotics within the previous 3 months
  • Pregnant or breastfeeding women
  • Any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the periodontists, might confound the results or poses an additional risk to the subject during participation in the study, such as renal insufficiency, malignancy, rheumatoid osteoarthritis, human immunodeficiency syndrome.
  • Patients with at least one tooth of mobility grade 0 or 1 and/or furcation involvement grade 0 or I according to Hamp

Treatment and study plan

Emdogain® FL

Device

Emdogain® FL is an enamel matrix derivative intended for subgingival and topical application in conjunction with scaling and root planing procedures to provide regeneration of tooth support lost due to periodontal disease. Emdogain® FL has been shown to be effective in residual pockets with probing depths from 5mm to 9mm with no furcation involvement in patients with adequate plaque control. Emdogain® FL has also been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.

Scaling and root planing

Other

Scaling and root planing procedures as part of non-surgical periodontal therapy involves mechanical removal of dental plaque and calculus using curettes and sonic scalers.

Primary outcomes

  1. Periodontal probing depth (PPD)

    Time frame: At baseline

    Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe

  2. Periodontal probing depth (PPD)

    Time frame: After 3 months

    Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe

  3. Periodontal probing depth (PPD)

    Time frame: After 6 months

    Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe

  4. Periodontal probing depth (PPD)

    Time frame: After 12 months

    Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe

Secondary outcomes

  1. CAL (mm)

    Time frame: At baseline, after 3, 6 and 12 months

    CAL (Clinical attachment level): the probing depth and the distance from the gingival margin to the CEJ API: Approximal plaque index PBI: Papillary Bleeding Index PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area GCF: Gingival crevicular fluid

  2. API, PBI (%)

    Time frame: At baseline, after 3, 6 and 12 months

    API: Approximal plaque index PBI: Papillary Bleeding Index

  3. PESA, PISA (mm2)

    Time frame: At baseline, after 3, 6 and 12 months

    PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area

  4. GCF markers for periodontal regeneration

    Time frame: At baseline, after 3, 6 and 12 months

    GCF: Gingival crevicular fluid

  5. Periodontal bacteria

    Time frame: At baseline, after 3, 6 and 12 months

    Microbiologic evaluation of GCF via polymerase chain reaction (PCR) DNA probe test kit

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 26, 2020
Registry last updated
Oct 25, 2022

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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