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Small‐diameter titanium grade IV and titanium–zirconium implants in edentulous mandibles: Ten‐year results from a double‐blind, randomised controlled split‐mouth core‐trial


Müller, Frauke; Al‐Nawas, Bilal; Storelli, Stefano; Quirynen, Marc; Hicklin, Stefan; Castro‐Laza, Jose; Bassetti, Mario; Srinivasan, Murali (2024). Small‐diameter titanium grade IV and titanium–zirconium implants in edentulous mandibles: Ten‐year results from a double‐blind, randomised controlled split‐mouth core‐trial. Clinical Oral Implants Research, 35(1):77-88.

Abstract

The goal of this extension study was to compare the 10‐year outcome of 3.3 mm diameter titanium–zirconium (TiZr) or grade IV titanium (Ti) implants in mandibular implant‐overdentures.Materials and MethodsThis study is the 10‐year follow‐up from a randomised, controlled, double‐blind, split‐mouth multicentre clinical trial. Patients with edentulous mandibles had received two implants in the interforaminal region (bone‐level, diameter 3.3 mm, microrough surface), one of TiZr (test) and one of Ti (control). Implant survival and success, plaque and sulcus bleeding indices, probing pocket depth, gingival margin, clinical attachment level and radiographic crestal bone levels were evaluated.ResultsFifty of 91 patients with implants were available for the 10‐year examination and 36 patients were valid for the intent‐to‐treat (ITT) analysis. The implant success rate was calculated as 94.6% and 91.9% for the TiZr implants and the Ti implants respectively. Four implants were lost (TiZr = 1; Ti = 3) in the entire study period. Kaplan–Meier survival analyses estimated 10‐ year implant survival rate for TiZr to 98.9% and Ti 95.8%.The mean of total and functional crestal bone loss was 1.49 mm (±1.37 mm) and 0.82 mm (±1.09 mm) in the TiZr group and 1.56 mm (±1.34 mm) and 0.85 mm (±1.16 mm) in the Ti group.ConclusionsThis split‐mouth design RCT on mandibular implant‐overdentures evidenced, bearing in mind its follow‐up time‐related reduced cohort size, high 10‐year implant success‐ and survival rates. These results confirm TiZr as well‐suited implant material for realising small‐diameter implants.Registered on www.clinicaltrials.gov: NCT01878331.

Abstract

The goal of this extension study was to compare the 10‐year outcome of 3.3 mm diameter titanium–zirconium (TiZr) or grade IV titanium (Ti) implants in mandibular implant‐overdentures.Materials and MethodsThis study is the 10‐year follow‐up from a randomised, controlled, double‐blind, split‐mouth multicentre clinical trial. Patients with edentulous mandibles had received two implants in the interforaminal region (bone‐level, diameter 3.3 mm, microrough surface), one of TiZr (test) and one of Ti (control). Implant survival and success, plaque and sulcus bleeding indices, probing pocket depth, gingival margin, clinical attachment level and radiographic crestal bone levels were evaluated.ResultsFifty of 91 patients with implants were available for the 10‐year examination and 36 patients were valid for the intent‐to‐treat (ITT) analysis. The implant success rate was calculated as 94.6% and 91.9% for the TiZr implants and the Ti implants respectively. Four implants were lost (TiZr = 1; Ti = 3) in the entire study period. Kaplan–Meier survival analyses estimated 10‐ year implant survival rate for TiZr to 98.9% and Ti 95.8%.The mean of total and functional crestal bone loss was 1.49 mm (±1.37 mm) and 0.82 mm (±1.09 mm) in the TiZr group and 1.56 mm (±1.34 mm) and 0.85 mm (±1.16 mm) in the Ti group.ConclusionsThis split‐mouth design RCT on mandibular implant‐overdentures evidenced, bearing in mind its follow‐up time‐related reduced cohort size, high 10‐year implant success‐ and survival rates. These results confirm TiZr as well‐suited implant material for realising small‐diameter implants.Registered on www.clinicaltrials.gov: NCT01878331.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Center for Dental Medicine > Clinic of Conservative and Preventive Dentistry
04 Faculty of Medicine > Center for Dental Medicine > Klinik für Allgemein-, Behinderten- und Seniorenzahnmedizin
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > Oral Surgery
Uncontrolled Keywords:Oral Surgery
Language:English
Date:1 January 2024
Deposited On:29 Dec 2023 12:03
Last Modified:30 Apr 2024 01:45
Publisher:Wiley-Blackwell Publishing, Inc.
ISSN:0905-7161
OA Status:Hybrid
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1111/clr.14199
Related URLs: (Organisation)
PubMed ID:37942666
  • Content: Published Version
  • Language: English
  • Licence: Creative Commons: Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)