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

Maurizio S Tonetti, Pierpaolo Cortellini, Gaia Pellegrini, Michele Nieri, Daniele Bonaccini, Mario Allegri, Philippe Bouchard, Francesco Cairo, Gianpaolo Conforti, Ioannis Fourmousis, Filippo Graziani, Adrian Guerrero, Jan Halben, Jacques Malet, Giulio Rasperini, Heinz Topoll, Hannes Wachtel, Beat Wallkamm, Ion Zabalegui, Otto Zuhr, Maurizio S Tonetti, Pierpaolo Cortellini, Gaia Pellegrini, Michele Nieri, Daniele Bonaccini, Mario Allegri, Philippe Bouchard, Francesco Cairo, Gianpaolo Conforti, Ioannis Fourmousis, Filippo Graziani, Adrian Guerrero, Jan Halben, Jacques Malet, Giulio Rasperini, Heinz Topoll, Hannes Wachtel, Beat Wallkamm, Ion Zabalegui, Otto Zuhr

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: One hundred and eighty-seven 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. The primary outcome was changed 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 min shorter (95%CI from 11.9 to 19.6, p < .0001) and perceived lighter (11.9 VAS units, 95%CI from 4.6 to 19.1, p = .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.

Keywords: collagen matrix; coronally advanced flap; gingival recession; human; randomized controlled clinical trial; root coverage.

© 2017 The Authors. Journal of Clinical Periodontology Published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
CONSORT patient accountability diagram
Figure 2
Figure 2
Perception of pain and OHIP‐14 scores after surgery. Average postoperative pain values (a) and OHIP‐14 scores (b) representative of the previous 24 hr during the first 14 days after surgery in subjects treated with CTG (blue continuous line) and CMX (orange dashed line). Pain values are expressed on a 100‐mm visual analogue scale (values under 30 are considered to be moderate pain). Intergroup differences for pain were significant at 7 days. OHIP‐14 scores are expressed as total scores (values ranging from 0 to 56, with higher scores indicating greater impact). OHIP scores were lower in CMX patients at days 1, 3 and 7. The time necessary to return to baseline OHIP scores (time to recovery) was 1.8 days shorter in CMX‐treated subjects
Figure 3
Figure 3
Number of teeth with complete root coverage over time. Number of teeth with complete root coverage at different time points in subjects treated with CTG (blue continuous line) and CMX (orange dashed line)

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Source: PubMed

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