Skip to main content
OpenTrials
Completed

NCT Number: NCT04271423

Ridge Preservation Comparing a Flap Versus Flapless Technique

To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have one non-molar tooth requiring extraction that will be replaced with a dental implant where at least one adjacent tooth is present
  • Study subjects at least 18 years old
  • Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.

Exclusion criteria

  • Patients with debilitating systemic disease, or a disease affects the periodontium
  • Have an allergy to any material or medication used in the study
  • Require prophylactic antibiotics
  • Previous head and neck radiation therapy
  • Chemotherapy in the previous 12 months
  • Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy
  • Smoked more than one pack of cigarettes per day

Treatment and study plan

Ridge Preservation

Procedure

Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.

Primary outcomes

  1. Crestal Horizontal Ridge Width

    Time frame: 4 months after surgery

    Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper.

Secondary outcomes

  1. Percent osseous tissue

    Time frame: 4 months after surgery

    A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Alveolar Ridge Preservation Using a Flap Versus Flapless Technique Using a Demineralized Bone Matrix Allograft Plus Mineralized Particulate Allograft and a Calcium Sulfate Barrier

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 17, 2020
Registry last updated
Jun 6, 2023

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.

Published trials that share one or more normalized conditions with this study.