Recruiting

Guided Bone Regeneration

Sponsor:

University of Louisville

Code:

NCT06353399

Conditions

Ridge Augmentation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Intra-marrow penetrations

No Intra-marrow penetrations

Study Details

Brief summary:

The primary aims of this study are to compare, after 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures.

Conditions

Ridge Augmentation

Study ID

NCT06353399

Start date

Jun 15, 2023

Status verified date

Apr, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy male or female who is at least 18 years old.
  • Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

  • Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
  • Presence or history of osteonecrosis of jaws.
  • Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
  • Patients who have been treated with oral bisphosphonates for more than three years.
  • Patients with an allergy to any material or medication used in the study.
  • Patients who need prophylactic antibiotics
  • Previous head and neck radiation therapy.
  • Chemotherapy in the previous 12 months.
  • Patients on long term NSAID or steroid therapy.
  • Pregnant patients.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intra-marrow penetrations

Twelve test patients will receive guided bone regeneration therapy with the use of intra-marrow penetrations prior to bone graft placement.

active comparator: No Intra-marrow penetrations

Twelve test patients will receive guided bone regeneration therapy without the use of intra-marrow penetrations prior to bone graft placement.

Interventions

Intra-marrow penetrations

Intra-marrow penetrations

No Intra-marrow penetrations

No Intra-marrow penetrations

Primary outcome measure

  • Alveolar Ridge Width [ Time Frame: 6 Months ]
  • Alveolar Ridge Height [ Time Frame: 6 Months ]
  • Buccal Soft Tissue Thickness [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Himabindu Dukka, DMD

502-852-1817himabindu.dukka@louisville.edu

Niti Patel, DMD

502-852-1817ndpate02@louisville.edu

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Bindu Dukka, BDS, MSD, MPH

502- 852- 1817himabindu.dukka@louisville.edu

Niti Patel, DMD

859-685-5423niti.patel@louisville.edu

Principal Investigator:

Bindu Dukka, BDS, MSD, MPH

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

More Information

Sponsor

University of Louisville

Last update posted

Apr 9, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2024-04-09.