Effect of Healing Time on New Bone Formation Following Tooth Extraction and Ridge Preservation With Demineralized Freeze-Dried Bone Allograft

Completed · Not applicable

Conditions studied: Bone Augmentation

In brief

Bone grafting following tooth extraction is commonly performed to preserve bony ridge dimensions adequate to support subsequent implant placement. Alveolar ridge resorption commonly occurs following tooth extraction, and the decrease in bone volume has the potential to make dental implant therapy impossible without surgery to reconstruct the ridge. The aim of ridge preservation grafting is to prevent or minimize this resorptive process, thereby preserving an adequate volume of bone for implant placement. Ridge preservation generally involves placement of a particulate bone graft material in the tooth socket, followed by use of a membrane or similar substance over the socket entrance to contain the bone graft. Various grafting materials have been recommended for these ridge preservation procedures, including demineralized freeze-dried bone allograft (DFDBA). The timing of dental implant placement following ridge preservation procedures is controversial, and few studies have examined the effects of different healing time intervals between ridge preservation and implant placement. The purpose of this project is to evaluate the formation of new bone at a site where tooth extraction has been performed followed by grafting using DFDBA. Two different study groups are included, one having the dental implant placed 8-10 weeks after tooth extraction and ridge grafting, the other having the dental implant placed 18-20 weeks after extraction and grafting.

Key facts

Study ID: NCT02154386
Run by: The University of Texas Health Science Center at San Antonio
People needed: 46
Starts: 2013-10-01
Expected to finish: 2015-05-01
Last updated by the study team: 2015-12-03

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patient currently a patient at dental school or eligible for treatment at dental school
Patient resides within 50 mile radius of dental school
A single rooted tooth that has been identified by dental faculty as requiring extraction
Have adequate restorative space for a dental implant-retained restoration
Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.

You may not qualify if…

not meeting inclusion criteria above
Active localized or systemic infection other than periodontitis.
Inadequate bone dimensions or restorative space dimensions to place a dental implant
Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy.
Positive medical history of endocarditis following oral or dental surgery.
Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants (per package insert)

Where it is running

UT Health Science Center School of Dentistry — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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