Last reviewed · How we verify

NCT06191510

Xenogenic Bone Intentionally Left Exposed

Completed Last updated 5 August 2024
What this trial tests

trial testing Bio-Oss Exposed in Soft Tissue in 28 participants. Completed in 15 June 2022.

Timeline
17 December 2019
Primary endpoint
14 April 2022
15 June 2022

Quick facts

Lead sponsorUniversity of Sao Paulo
StatusCompleted
Study typeOBSERVATIONAL
Enrollment28
Start date17 December 2019
Primary completion14 April 2022
Estimated completion15 June 2022
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 90, any sex, with Soft Tissue or Dental Implants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to compare, the effect of letting the xenogeneic bone graft exposed to the oral environment or seal off the graft with a collagen matrix. Them main questions it aims to answer are: * The enhancement of soft tissue healing during the initial phases following immediate implant placement. * The secondary aim is to evaluate the dimensional alterations in hard tissues at immediately placed implants and different biomaterial protocol. It were selected patients with indication of flapless extraction in posterior teeth, which was placed immediate implant (n=28) and gap filling with deproteinized bovine bone mineral (Geistlich Bio-Oss®). In this study, participants were stratified into two randomized blocks, each corresponding to a distinct surgical technique: left exposed the graft to the oral environment or coverage with a collagen matrix (Geistlich Mucograft®). * Previously the extraction was performed the measurement of the keratinized gingiva, and after 04 months of implant placement. * The soft tissue healing was evaluated on days 02, 07, 30 days; by means of a blue-stained solution (methylene blue 0.05%) and standardized photograph. * In the same date from different healing times it was performed immunoenzymatic analysis of the levels of VEGF (vascular endothelial growth factor), IL-1β (interleukin-1β) and FGF2 (fibroblast growth factor 2). * It was also be performed cone beam computed tomography images quantifying the soft and hard tissues thickness of the facial and lingual bone wall. The clinical trial examiner was blinded during the study period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Soft Tissue

Currently open trials in the same condition.

Other University of Sao Paulo trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06191510.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing