Xenogenic Collagen Matrix or Autologous Connective Tissue Graft as Adjunct to Coronally Advanced Flaps for Coverage of Multiple Adjacent Gingival Recession Randomized Trial Assessing non-Inferiority in Root Coverage and Superiority in Oral Health Related Quality of Life

Abstract

Aim

To evaluate the non-inferiority of the adjunct of a xenogeneic collagen matrix (CMX) or connective tissue graft (CTG) to coronally advanced flaps (CAF) for coverage of multiple adjacent recessions and compare superiority in patient reported outcomes (PROM).

Material and Methods

187 subjects (92 CMX) with 485 recessions in 14 centres were randomized and followed-up for 6-months. Patients filled daily diaries for 15 days to monitor patient reported experience. Primary outcome was change in position of the gingival margin. Multilevel analysis used centre, subject, and tooth as levels and baseline parameters as covariates.

Results

Average baseline recession was 2.5 ± 1.0 mm. The surgery was 15.7 minutes shorter (95%CI from 11.9 to 19.6, P<0.0001) and perceived lighter (11.9 VAS units, 95%CI from 4.6 to 19.1, P=0.0014) in CMX subjects. Time to recovery was 1.8 days shorter in CMX. Six-month root coverage was 1.7 ± 1.1 mm for CMX and 2.1 ± 1.0 mm for CTG (difference of 0.44 mm, 95%CI from 0.25 to 0.63 mm). The upper limit of the confidence interval was over the non-inferiority margin of 0.25 mm. Odds of complete root coverage were significantly higher for CTG (OR = 4.0, 95% CI 1.8–8.8).

Conclusion

Replacing CTG with CMX shortens time to recovery and decreases morbidity but the tested generation of devices is probably inferior to autologous CTG in terms of root coverage. Significant variability in PROMs was observed among centres.

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