A multicenter randomized controlled trial using a novel collagen membrane for guided bone regeneration at dehisced single implant sites: Outcome at prosthetic delivery and at 1-year follow-up.
Clin Oral Implants Res
; 30(6): 487-497, 2019 Jun.
Article
en En
| MEDLINE
| ID: mdl-30927498
ABSTRACT
OBJECTIVES:
To compare clinical performance of a novel resorbable non-cross-linked collagen membrane (CXP) with a reference membrane (non-cross-linked resorbable membrane; BG) for simultaneous implant placement and guided bone regeneration (GBR) at dehisced single implant sites. MATERIALS ANDMETHODS:
Preliminary data from this randomized controlled trial were reported previously; this is the 12-month report. The primary outcome measure was defected height at 6 months post-GBR. Secondary outcomes included implant cumulative survival rate (CSR) and success rate since placement; bone level changes, pink esthetic score (PES), and patient satisfaction since definitive prosthesis delivery; patient quality of life since pretreatment; and the 1-year bleeding index. Non-parametric statistical analyses were performed.RESULTS:
Among patients, 24 were treated with CXP and 25 with BG. The 1-year implant CSR and success rate were 100% (n = 42). Bone level change between definitive prosthetic delivery and 1 year was not significantly different between the CXP and BG groups (BG + 0.42 mm, CXP + 0.01 mm). The PES increased from 7.55 to 8.10 for the CXP group and from 6.48 to 7.48 for the BG group; 1-year bleeding indices were 0 (16 CXP, 18 BG) and 1 (4 CXP, 2 BG). Patient quality of life changed from an OHIP-14 score of 6.5 at pretreatment to 1.9 at 1 year. Overall satisfaction (visual analogue score) with function and esthetics was 9.9 and 9.7, respectively. Inter-group differences were not significant for assessed outcomes. No device-related adverse events were reported.CONCLUSIONS:
The use of CXP and BG for simultaneous implant placement and GBR at dehisced implant sites similarly reduced defect height and improved secondary measures, indicating non-inferiority.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Calidad de Vida
/
Implantación Dental Endoósea
Tipo de estudio:
Clinical_trials
/
Observational_studies
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Prognostic_studies
Límite:
Humans
Idioma:
En
Año:
2019
Tipo del documento:
Article