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TerminatedNCT03580798Updated Sep 10, 2020

Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

An interventional study of Delayed graft and Simultaneous graft in Tooth Loss, sponsored by University of Louisville. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-10.

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

Why this study was terminated
Not enough patients available
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.

Read the detailed description

The primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by Buser (test group).

02

Conditions studied

  • Tooth Loss

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03

In context

Tooth Loss

224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.

This study's enrollment of 7 is below the median of 30 across 166 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

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

  • Have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by 2 teeth.
  • Healthy persons at least 18 years old.
  • Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion criteria

Exclusion Criteria:

  • Patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium.
  • Exclude any molar tooth.
  • Presence of or history of osteonecrosis of jaws.
  • Patients with current or previous history of IV bisphosphonates, irrespective of duration.
  • Patients taking oral bisphosphonates for ≥ 3 years.
  • Pregnant women.
  • Allergy to any material or medication used in the study.
  • Patients who need prophylactic antibiotics prior to dental procedures.
  • Previous head and neck radiation therapy.
  • Chemotherapy in the previous 12 months.
05

Study design

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

Study arms

  • Experimental
    Delayed Grafting

    8 weeks after extraction implant placement and simultaneous osseous grafting.

    Procedure: Delayed graft

  • Active comparator
    Simultaneous Grafting

    At the time of extraction the socket will be grafted and implant placed 4 months later.

    Procedure: Simultaneous graft

Interventions

  • ProcedureDelayed graft

    8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.

  • ProcedureSimultaneous graft

    At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.

06

What researchers measure

Primary outcomes

  1. Final ridge width for simultaneous and delayed grafting treatment.

    Measure final ridge width to determine if adequate bone is available.

    Time frame: 16 to 20 weeks

Secondary outcomes

  1. Soft tissue thickness

    Facial and occlusal

    Time frame: 16 to 20 weeks

  2. Histology

    Histologic composition for control group only

    Time frame: 16 weeks

  3. Implant dehiscence

    Implant dehiscence

    Time frame: 20 weeks

07

Study locations

1 site
  • Graduate Periodontics, UofL School of Dentistry
    Louisville, Kentucky 40202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03580798
Lead sponsor
University of Louisville
Responsible party
Henry Greenwell (Director of Graduate Peridontics, University of Louisville) — Principal investigator
First posted
Jul 9, 2018
Start date
Nov 8, 2018
Primary completion
Apr 26, 2019
Completion
Apr 26, 2019
Last update
Sep 10, 2020

Study contacts

Henry Greenwell, DMD
principal investigator · University of Louisville

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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