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OpenTrials
Completed

NCT Number: NCT05419102

Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)

The existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann USA). Various clinical factors were gathered from the existing records. Some of the factors recorded were: retention of the implant, presence of bleeding, presence of further damage, and presence of inflammation. All patients had signed an informed consent for treatment and the anonymous use of their data for research purposes. All HIPA requirements were followed.

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Key information

Conditions

Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

North Dallas Dental Health

Dallas, Texas, 75221, United States

About this study

See brief summary.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all adult patients of record who presented with existing peri-implantitis that was clinically deemed treatable (the implant was not considered hopeless.)

Exclusion criteria

  • none except for routine medical contraindications for periodontal surgery

Treatment and study plan

peri-implantitis surgery with enamel matrix derivative

Procedure

surgical procedures around dental implants with peri-implantits to remove infectious material and apply enamel matrix derivative to the implant.

Primary outcomes

  1. retention of the implant

    Time frame: 0.71 to 6.4 years

    Determine if the implant was still present at the time of reevaluation

Secondary outcomes

  1. record the clinical condition of the implant at the time of reevaluation

    Time frame: 0.71 to 6.4 years

    Multiple standard measurements of the clinical condition of the implant were recorded at the time of reevaluation

Sponsors and collaborators

Lead sponsor

North Dallas Dental Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2022
Registry last updated
Jun 15, 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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