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.

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 / M. Tonetti, P. Cortellini, G. Pellegrini, M. Nieri, D. Bonaccini, M. Allegri, P. Bouchard, F. Cairo, G. Conforti, I. Fourmousis, F. Graziani, A. Guerrero, J. Halben, J. Malet, G. Rasperini, H. Topoll, H. Wachtel, B. Wallkamm, I. Zabalegui, O. Zuhr. - In: JOURNAL OF CLINICAL PERIODONTOLOGY. - ISSN 1600-051X. - 45:1(2018 Jan), pp. 78-88. [10.1111/jcpe.12834]

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

G. Pellegrini;G. Rasperini;
2018

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.
collagen matrix; coronally advanced flap; gingival recession; human; randomized controlled clinical trial; root coverage
Settore MED/28 - Malattie Odontostomatologiche
gen-2018
Article (author)
File in questo prodotto:
File Dimensione Formato  
Tonetti 2018.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 665.29 kB
Formato Adobe PDF
665.29 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/566211
Citazioni
  • ???jsp.display-item.citation.pmc??? 20
  • Scopus 90
  • ???jsp.display-item.citation.isi??? 84
social impact