Regenerative Surgical Treatment of Peri-implant Defects

  • STATUS
    Recruiting
  • participants needed
    44
  • sponsor
    University of Santiago de Compostela
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Updated on 5 August 2020
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Summary

Does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high.

Nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. Also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and human case series-studies have shown improved outcomes when using a submerged healing approach. However, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.

Description

The present study will be double-blinded randomized controlled clinical trial. Patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either:

Test group: submerged healing or Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.

The primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on X-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis.

Secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications and implant loss.

Details
Condition Implant Site Pocket Infection
Age 18years - 100years
Treatment regenerative treatment periimplantitis
Clinical Study IdentifierNCT04440241
SponsorUniversity of Santiago de Compostela
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 years
Systemically healthy patients
Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth 6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss 3mm) according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component
Absence of mobility of the implants
Individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded)
Patient's smoking 10 cigarettes/day

Exclusion Criteria

Non-removable prostheses
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