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NCT06191510
Xenogenic Bone Intentionally Left Exposed
trial testing Bio-Oss Exposed in Soft Tissue in 28 participants. Completed in 15 June 2022.
14 April 2022
Quick facts
| Lead sponsor | University of Sao Paulo |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 28 |
| Start date | 17 December 2019 |
| Primary completion | 14 April 2022 |
| Estimated completion | 15 June 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Bio-Oss Exposed
- Mucograft Exposed
Conditions studied
- Soft Tissue — all drugs for Soft Tissue →
- Dental Implants — all drugs for Dental Implants →
- Healing Wound — all drugs for Healing Wound →
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:
- PubMed search for NCT06191510
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06191510 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
- Last refreshed: 5 August 2024
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