Surgical treatment of periodontal intrabony defects with calcium sulfate implant and barrier versus collagen barrier or open flap debridement alone: a 12-month randomized controlled clinical trial.
BACKGROUND: This randomized controlled clinical trial was designed to compare the
clinical outcomes of guided tissue regeneration with calcium sulfate graft and
membrane (CS) versus guided tissue regeneration with collagen membrane (CM) or
open flap debridement (OFD) only in terms of clinical attachment gain in
periodontal intrabony defects.
METHODS: Fifty-one systemically healthy, non-smoking subjects affected by
moderate to severe chronic periodontitis were recruited. The subjects had one
deep intrabony defect with a probing depth (PD) > or =6 mm and were randomly
divided into three equal groups (17 subjects per group). Subjects were surgically
treated with OFD (OFD group), OFD with CS (CS group), or OFD and CM (CM group).
One year after surgical treatment, a complete clinical examination and a surgical
reentry were performed. The pre- and post-therapy clinical parameters, including
PD, clinical attachment level (CAL), gingival recession (GR), and intrasurgical
parameters (defect bone level [DBL]), were compared.
RESULTS: After 1 year, the clinical and intrasurgical parameters showed
statistically significant changes from baseline within each group for all of the
evaluated parameters (PD and CAL, P <0.001; GR and DBL, P <0.05). Differences
(PD, CAL, and DBL, P <0.001; GR, P <0.05) were also seen across the three groups.
The CM and CS groups had significantly smaller PD, CAL, and DBL values than
subjects treated with only OFD. Groups treated with regenerative techniques had a
significantly greater PD reduction and CAL and DBL gain compared to the OFD
group. No significant differences were seen between CM and CS. Conversely, the CM
group showed a significantly greater GR increase compared to OFD and CS.
CONCLUSIONS: Both regenerative treatments produced additional clinical benefits
over OFD alone. Moreover, the use of CS may minimize post-surgical recession.