A randomized, parallel design, single blind study comparing atrisorb barriers formed in situ, or the barrier forming kit, over decalcified freeze-dried bone allograft (DFDBA), to DFDBA alone for treatment of class II furcation defects
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Abstract
The Aim of this randomized, single-blind, parallel design study was to show superiority of vertical and/or horizontal attachment level improvement at twelve months for a combined therapy of DFDBA plus ATRISORB[TM]barrier, over DFDBA alone (primary outcome) in treatment of human class II furcation defects. The secondary outcome variable was probing depth changes. Thirty-six patients were randomized in 3 treatment groups: l) DFDBA plus ATRISORB[TM] Barrier prepared using the barrier-forming kit (12 patients), 2) DFDBA plus ATRISORB[TM] Barrier formed in situ (12 patients), or 3) DFDBA alone (12 patients). Efficacy evaluations, including pocket depth (PD), bleeding on probing (BOP), and clinical attachment levels (in the horizontal direction, CAL-H; in the vertical direction, CAL-V) were performed at months 4, 6, 9 and 12. Surgical treatment resulted in clinically and statistically equivalent changes when comparisons were made between all treatment groups. The mean probing depth reductions were DFDBA+ in situ = 2.4 mm, DFDBA+ kit = 2 mm and DFDBA alone = 2.3 mm. At 9- month evaluation, the CAL-V gains in the DFDBA + in situ and DFDBA alone were 1.25 mm and 1.58 mm, respectively. Both of these gains were significant, while in the DFDBA + kit the CAL-V gains at 9-month evaluation were 0.09 mm and it was not significant. The changes between the 9 and 12 month observation periods in DFDFA + kit group was significant. The net gains in attachment for the DFDBA + in situ, DFDBA + kit and DFDBA alone were 1.72 mm, 0.73 mm and 1.58 mm, respectively. All of these gains were significant. At 12-month evaluation there was no significant difference in CAL-V between all treatment groups. The net gains in CAL-H in the DFDBA + in situ, DFDBA + kit and DFDBA alone were 2.17 mm, 1.27 mm and 1.5 mm, respectively. All of these gains were significant. There was no significant difference in CAL-H between all treatment groups. BOP (which had a mean score of 1.33 at baseline for all three treatment groups) was statistical significantly reduced at the 4-months evaluation in all three treatment groups. These minimal levels of BOP were maintained through the observation period. All treatment modalities used in this study, including DFDBA alone showed significant improvements in clinical parameters when compared to baseline. No treatment group proved to be significantly better than the other.
Description
Thesis (M.Sc.D.)--Boston University, Henry M. Goldman School of Dental Medicine, 1999.
Includes bibliographical references (leaves 63-71).
Includes bibliographical references (leaves 63-71).
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This work is being made available in OpenBU by permission of its author, and is available for research purposes only. All rights are reserved to the author.