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Randomized controlled clinical study evaluating effectiveness and safety of a volume‐stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites
Author(s) -
Thoma Daniel S.,
Zeltner Marco,
Hilbe Monika,
Hämmerle Christoph H. F.,
Hüsler Jürg,
Jung Ronald E.
Publication year - 2016
Publication title -
journal of clinical periodontology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.456
H-Index - 151
eISSN - 1600-051X
pISSN - 0303-6979
DOI - 10.1111/jcpe.12588
Subject(s) - soft tissue , dentistry , medicine , implant , hard tissue , connective tissue , materials science , surgery , pathology
Aim To test whether or not the use of a collagen matrix ( VCMX ) results in short‐term soft tissue volume increase at implant sites non‐inferior to an autogenous subepithelial connective tissue graft ( SCTG ), and to evaluate safety and tissue integration of VCMX and SCTG . Methods In 20 patients with a volume deficiency at single‐tooth implant sites, soft tissue volume augmentation was performed randomly allocating VCMX or SCTG . Soft tissue thickness, patient‐reported outcome measures ( PROM s), and safety were assessed up to 90 days ( FU ‐90). At FU ‐90 (abutment connection), tissue samples were obtained for histological analysis. Descriptive analysis was computed for both groups. Non‐parametric tests were applied to test non‐inferiority for the gain in soft tissue thickness at the occlusal site. Results Median soft tissue thickness increased between BL and FU ‐90 by 1.8 mm (Q1:0.5; Q3:2.0) ( VCMX ) ( p = 0.018) and 0.5 mm (−1.0; 2.0) ( SCTG ) ( p = 0.395) (occlusal) and by 1.0 mm (0.5; 2.0) ( VCMX ) ( p = 0.074) and 1.5 mm (−2.0; 2.0) ( SCTG ) ( p = 0.563) (buccal). Non‐inferiority with a non‐inferiority margin of 1 mm could be demonstrated ( p = 0.020); the difference between the two group medians (1.3 mm) for occlusal sites indicated no relevant, but not significant superiority of VCMX versus SCTG (primary endpoint). Pain medication consumption and pain perceived were non‐significantly higher in group SCTG up to day 3. Median physical pain ( OHIP ‐14) at day 7 was 100% higher for SCTG than for VCMX . The histological analysis revealed well‐integrated grafts. Conclusions Soft tissue augmentation at implant sites resulted in a similar or higher soft tissue volume increase after 90 days for VCMX versus SCTG . PROM s did not reveal relevant differences between the two groups.