Clinical and Radiographic Evaluation of Demineralized Freeze-Dried Bone Allograft Versus Platelet Rich Fibrin for the Treatment of Periodontal Intrabony Defects in Humans

Completed · Not applicable

Conditions studied: Periodontitis

In brief

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.

Key facts

Study ID: NCT02154906
Run by: The University of Texas Health Science Center at San Antonio
People needed: 44
Starts: 2013-11-01
Expected to finish: 2016-04-01
Last updated by the study team: 2016-07-01

Who can join

Age: 18 and older, up to 99. 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 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

You may not qualify if…

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

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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