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Completed

NCT Number: NCT05592158

Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation

This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM.

30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age range: 20 to 80 years.
  • Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
  • Socket should be free of infection, less than 5mm of dehiscence
  • Patients interested in implant placement following tooth extraction.

Exclusion criteria

  • Allergies or hypersensitivities to study related medications such as chlorhexidine.
  • Hematologic disorders/blood dyscrasias.
  • Active infectious diseases of any kind.
  • Liver or kidney dysfunction/failure.
  • Uncontrolled diabetes (HbA1c > 8).
  • Active cancer treatment - such as active chemotherapy or radiation therapy.
  • Taking medications that will affect their bone healing (for example, bisphosphonates).
  • Metabolic bone diseases that affect bone healing such as osteoporosis.
  • Pregnant or lactating women (self-reported).
  • Smoke 10 or more cigarettes per day (self-reported).
  • Poor oral hygiene.

Treatment and study plan

Socket preservation

Procedure

After tooth extraction, the socket will be filled with a collagen plug and covered with an amnion-chorion membrane.

Primary outcomes

  1. Clinical alveolar ridge dimension changes

    Time frame: 4 months

    Clinically measured alveolar ridge dimension changes in mm using calibers

  2. Digital alveolar ridge dimension changes

    Time frame: 4 months

    Digitally measured alveolar ridge dimension changes in mm2 using CBCT

Secondary outcomes

  1. Histological bone density.

    Time frame: 4 months

    Histomorphometry.

  2. Presence of bone turnover proteins.

    Time frame: 4 months

    Immunohistochemistry.

  3. Implant survival-Clinical

    Time frame: 6 months

    Clinically assessed by torque test using a torque wrench, measured in N/cm.

  4. Implant survival-Radiographic

    Time frame: 6 months

    Radiographically assessed through any signs of radiolucency around the implant.

  5. Esthetic restorative outcomes.

    Time frame: 6 months

    Clinical changes in hard tissue based on the PES score

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2022
Registry last updated
Mar 25, 2025

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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