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Completed

NCT Number: NCT01901783

Ridge Augmentation Without Primary Closure

This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.

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Key information

Conditions

Alveolar Ridge Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Graduate Periodontics Clinic University of Louisville

Louisville, Kentucky, 40202, United States

About this study

A maximum of 30 patients will be selected that meet the following criteria:

Inclusion criteria

  • At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  • Healthy person that is at least 18 years old.
  • Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion criteria

  • Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  • Previous head and neck radiation or chemotherapy within the previous 12 months.
  • Patients with known allergy to any of the materials that will be used in the study.
  • Smokers.
  • Patients who need prophylactic antibiotics prior to dental procedures.
  • Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  • Patients who are pregnant.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  • Healthy person that is at least 18 years old.
  • Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion criteria

  • Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  • Previous head and neck radiation or chemotherapy within the previous 12 months.
  • Patients with known allergy to any of the materials that will be used in the study.
  • Smokers.
  • Patients who need prophylactic antibiotics prior to dental procedures.
  • Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  • Patients who are pregnant.

Treatment and study plan

With primary closure

Procedure

A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will be primarily closed over the membrane.

Other names: Primary soft tissue closure over the membrane.

Without primary closure

Procedure

A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will not be primarily closed over the membrane.

Other names: No primary soft tissue closure over the membrane.

Primary outcomes

  1. Crestal ridge width

    Time frame: 4 months

    The ridge width at the crest will be compared between the two treatment groups.

Secondary outcomes

  1. Percent vital bone

    Time frame: 4 months

    The percent vital bone will be compared between the two treatment groups.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2013
Registry last updated
Dec 8, 2016

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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