Clinical trial NCT04338516: Ridge Preservation Using a Ossix™ Bone vs Bio-Oss® Collagen
Official title: Histological Evaluation of Healing Following Ridge Preservation Using a Composite Bovine Derived Xenograft or a Hydroxyapatite-Collagen Matrix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: TEETH EXTRACTION
Lead sponsor: Datum Dental LTD
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, parallel design, controlled study will assess the histologic healing of this Ossix™ Bone in humans and compare it to a Bio-Oss® Collagen that is well researched.

Subjects will be enrolled into 2 groups. Each subject will provide a single non-molar tooth site for study treatment. The tooth will be extracted, the extraction socket will be filled with one of the study bone grafts. No wound dressing or membrane will be used to cover the bone graft material as both materials can be used alone. An core biopsy will be collected after 16 weeks of healing during the implant placement.

The study will evaluate if there is a difference in histologic wound healing following tooth extraction and ridge preservation between groups treated with Bio-Oss® Collagen compared to Ossix™ Bone.


Eligibility criteria: Inclusion Criteria:

* One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction

  * A dental implant is indicated and treatment planned to replace the missing tooth
  * 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.
  * Are nonsmokers or former smokers. Current smokers may be included if they smoke \<10 cigarettes per day

Exclusion Criteria:

* Will not cooperate with the follow-up schedule. Patients will not be entered who are mentally incompetent, prisoners, or pregnant.

  * Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over the counter pregnancy test will be provided if pregnancy status is unknown or suspected).
  * Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
  * Smokers who smoke \>10 cigarettes per day
  * Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, 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.

Primary outcomes:
measure: percent vital bone formation,
timeFrame: 16 weeks
measure: percent residual graft material
timeFrame: 16 weeks
measure: percent fibrous tissue and marrow space
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio (UTHSA)
state: Texas
Study officials:
References: