N/A
N=41
Clinical and Radiographic Evaluation of Demineralized Freeze-Dried Bone Allograft Versus Platelet Rich Fibrin for the Treatment of Periodontal Intrabony Defects in Humans
Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT02154906 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Change in Clinical Attachment Level (CAL) — 1.21; 1.03 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DFDBA (Device); autologous platelet rich fibrin (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinical Attachment Level (CAL) |
1.21; 1.03 | — |
| SECONDARY Change in Radiographic Bone Level |
1.14; 1.10 | — |
Summary
Inflammatory periodontal disease often results in loss of bone around the teeth. Bone defects that have a certain size and shape (called intrabony or intraosseous defects) may be improved by using a graft material in the bony defect. The purpose of this study is to compare healing of periodontal intrabony defects that are treated using demineralized freeze dried bone allograft (DFDBA) versus autogenous platelet-rich fibrin.
The null hypotheses is that there will be no significant differences in bone fill, CAL gain, PD reduction or recession at sites treated with PRF compared to sites treated with DFDBA.
Eligibility Criteria
Inclusion Criteria
- Patient currently a patient at dental school or eligible for treatment at dental school
- Patient resides within 50 mile radius of dental school and is eligible for treatment in Graduate Periodontics Clinic
- Diagnosis of chronic periodontitis with a treatment plan that includes surgical treatment of an intrabony defect adjacent to a natural tooth
- Willing and able to provide informed consent and be available for multiple follow-up visits for the duration of the study
- One or more sites with 1) a probing depth of 6mm or greater (>6mm), 2) a radiographic bony defect depth of greater than 3mm (>3mm), 3) sufficient keratinized tissue to allow complete coverage of the defect with gingival flaps, and 4) radiographic base of bony defect at least 2mm coronal to the apex of the tooth
- Female patients who have undergone a hysterectomy, tubal ligation or menopause, and non-pregnant women of child-bearing potential
Exclusion Criteria
- not meeting inclusion criteria above
- Failure to attain adequate oral hygiene prior to surgery (minimum 80% plaque-free surfaces)
- History within the last 6 months of daily use of smokeless tobacco, pipe or cigar smoking, or cigarette smoking exceeding 10 cigarettes per day. Former smokers who quit more than 6 months before the study are eligible for enrollment. Current smokers who smoke less than 10 cigarettes per day are eligible for enrollment.
- Untreated acute or chronic infections in the region of the study site
- Tooth mobility of Grade 2 or higher at the tooth with the potential test site
- Clinical or radiographic signs of apical pathology, root fracture, untreated carious lesions on the root surface or at the CEJ, subgingival restorations on the tooth with the potential test site
- Sensitivity or allergy to Bacitracin, Gentamycin, Polymyxin B Sulfate, alcohol and/or surfactants
Data sourced from ClinicalTrials.gov (NCT02154906). 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.