Minimally Invasive Ponto Surgical procedure in comparison with the linear incision method with out tender tissue discount for bone conduction listening to implants: examine protocol for a randomized managed trial.
Trials. 2016 Nov 09;17(1):540
Authors: Calon TG, van Hoof M, van den Berge H, de Bruijn AJ, van Tongeren J, Hof JR, Brunings JW, Jonhede S, Anteunis LJ, Janssen M, Joore MA, Holmberg M, Johansson ML, Stokroos RJ
BACKGROUND: Over the past years, much less invasive surgical strategies with tender tissue preservation for bone conduction listening to implants (BCHI) have been launched such because the linear incision method mixed with a punch. Outcomes utilizing this method appear favorable when it comes to fee of peri-abutment dermatitis (PAD), esthetics, and preservation of pores and skin sensibility. Lately, a brand new standardized surgical method for BCHI placement, the Minimally Invasive Ponto Surgical procedure (MIPS) method has been developed by Oticon Medical AB (Askim, Sweden). This method goals to standardize surgical procedure by utilizing a novel surgical instrumentation equipment and decrease tender tissue trauma.
METHODS: A multicenter randomized managed trial is designed to match the MIPS method to the linear incision method with tender tissue preservation. The first investigation heart is Maastricht College Medical Heart. Sixty-two members will probably be included with a 2-year follow-up interval. Parameters are launched to quantify components akin to lack of pores and skin sensibility, dehiscence of the pores and skin subsequent to the abutment, pores and skin overgrowth, and beauty outcomes. A brand new kind of sampling methodology is included to assist within the estimation of issues. To achieve additional understanding of PAD, swabs and pores and skin biopsies are collected throughout follow-up visits for analysis of the bacterial profile and inflammatory cytokine expression. The first goal of the examine is to match the incidence of PAD through the first three months after BCHI placement. Secondary aims embrace the evaluation of parameters associated to surgical procedure, wound therapeutic, ache, lack of sensibility of the pores and skin across the implant, implant extrusion fee, implant stability measurements, dehiscence of the pores and skin subsequent to the abutment, and esthetic enchantment. Tertiary aims embrace evaluation of different components associated to PAD and a well being financial analysis.
DISCUSSION: That is the primary trial to match the not too long ago developed MIPS method to the linear incision method with tender tissue preservation for BCHI surgical procedure. Newly launched parameters and sampling methodology will help within the prediction of outcomes and issues after BCHI placement.
TRIAL REGISTRATION: Registered on the CCMO register within the Netherlands on 24 November 2014: NL50072.068.14 . Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618 . This trial is sponsored by Oticon Medical AB.
PMID: 27829464 [PubMed – indexed for MEDLINE]