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NCT03256409

Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence

Completed NA Last updated 22 August 2017
What this trial tests

NA trial testing Adherence mold and yeast and mesophyll aerobe in Adhesiveness in 10 participants. Completed in 20 June 2017.

Timeline
5 January 2016
Primary endpoint
11 January 2017
20 June 2017

Quick facts

Lead sponsorGastrovital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment10
Start date5 January 2016
Primary completion11 January 2017
Estimated completion20 June 2017

Drugs / interventions tested

Conditions studied

Sponsor

Gastrovital

Who can join

Adults 50 to 60, any sex, with Adhesiveness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study was to compare the surface roughness (Ra) of the implant retained mandibular bar overdenture (BOD) and the implant retained mandibular ball joint overdenture (BJOD) in jaw and its relation with the adhesion of molds and yeasts and mesophyll aerobe, in time 30 to 180 days in mouth. Five systems titanium bar CARES® and synOcta® Straumann® Dental Implant System, Holding AG Inc., Basel, Switzerland (BOD); and five systems joint ball Klockner® Implant System; Soadco Inc., Escaldes-Engordany; Andorra (BJOD), were used in two parallel groups of five participants, in an essay to simple blind person. To 30 to 180 days they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml). The Ra:um (the 30th and 180th): BOD, 0.965 - 1.351; BJOD, 1.325 - 2.384. Adhesion: molds and yeasts, BOD, 2.6 x 102 and 4.6 x 103; BJOD, 3.0 x 102 and 5.3 x 104. Adhesion: mesophyll aerobe, BOD, 3.8 x 106 and 5.8 x 106; BJOD, 4.3 x 106 and 7.1 x 107. The BOD and BJOD, present different Ra (P \< 0.05) to 30 to 180 days. To 30 days (P = 0.489) differences do not exist as regards the adhesion of molds and yeasts and mesophyll aerobe between both overdentures. To 180 days (P = 0.723) differences exist as regards the adhesion of mold and yeast and mesophyll aerobe, being major in BJOD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Surface roughness implant-retained mandibular bar and ball joint overdentures and adherence of microorganisms.
    Rocío V, Valenzuela D. · · 2018 · cited 1× · PMID 30369801 · DOI 10.4103/ejd.ejd_265_18

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