N/A
N=102
Wound Healing Following Tooth Extraction and Ridge Preservation Using DFDBA Alone in Particulate Fiber Form and in Combination With Xenograft
Dental Extraction · Wound Heal
Bottom Line
View on ClinicalTrials.gov: NCT05400213 ↗Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Jun 2025
Primary outcome: Primary: Percentage Vital Bone Formation — 37.33; 40.76; 24.46; 23.85 percentage of vital bone formation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vallos (DCP) (Device); Vallomix (DCF) (Device); Vallos-F (DPX) (Device); Vallomix-F (DFX) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Vital Bone Formation |
37.33; 40.76; 24.46; 23.85 | — |
| SECONDARY Percentage of Residual Graft Material |
16.25; 3.57; 23.39; 18.42 | — |
| SECONDARY Percentage of Connective Tissue at Time of Implant |
46.41; 55.67; 52.03; 57.73 | — |
| SECONDARY Change in Ridge Width (Clinical Measurement) |
-1.19; -1.02; -1.15; -1.00 | — |
| SECONDARY Change in Buccal Ridge Height (Clinical Measurement) |
-1.67; -0.85; -0.41; -1.08 | — |
| SECONDARY Change in Lingual Ridge Height (Clinical Measurement) |
-1.85; -0.75; -1.17; -1.75 | — |
Summary
The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.
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
- 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.
Data sourced from ClinicalTrials.gov (NCT05400213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.