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CompletedNCT01901783Updated Dec 8, 2016

Ridge Augmentation Without Primary Closure

An interventional study of With primary closure and Without primary closure in Alveolar Ridge Augmentation, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-08.

Sponsored by University of Louisville · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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

Inclusion Criteria

  1. 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.
  2. Healthy person that is at least 18 years old.
  3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

  1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  2. Previous head and neck radiation or chemotherapy within the previous 12 months.
  3. Patients with known allergy to any of the materials that will be used in the study.
  4. Smokers.
  5. Patients who need prophylactic antibiotics prior to dental procedures.
  6. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  7. Patients who are pregnant.
02

Conditions studied

  • Alveolar Ridge Augmentation

Keywords

  • allograft
  • regeneration
  • alveolar ridge
03

In context

Lead sponsor

University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.
  2. Healthy person that is at least 18 years old.
  3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion criteria

Exclusion Criteria:

  1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  2. Previous head and neck radiation or chemotherapy within the previous 12 months.
  3. Patients with known allergy to any of the materials that will be used in the study.
  4. Smokers.
  5. Patients who need prophylactic antibiotics prior to dental procedures.
  6. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
  7. Patients who are pregnant.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    With primary closure

    The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.

    Procedure: With primary closure

  • Experimental
    Without primary closure

    The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.

    Procedure: Without primary closure

Interventions

  • ProcedureWith primary closure

    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.

    Also known as: Primary soft tissue closure over the membrane.

  • ProcedureWithout primary closure

    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.

    Also known as: No primary soft tissue closure over the membrane.

06

What researchers measure

Primary outcomes

  1. Crestal ridge width

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

    Time frame: 4 months

Secondary outcomes

  1. Percent vital bone

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

    Time frame: 4 months

07

Study locations

1 site
  • Graduate Periodontics Clinic University of Louisville
    Louisville, Kentucky 40202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01901783
Lead sponsor
University of Louisville
Responsible party
Henry Greenwell (Professor, University of Louisville) — Principal investigator
First posted
Jul 17, 2013
Start date
Sep 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Dec 8, 2016

Study contacts

Henry Greenwell, DMD
principal investigator · University of Louisville

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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