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Xenogenic Bone Intentionally Left Exposed

NCT06191510 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2024-08-05

No results posted yet for this study

Summary

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.

Conditions

  • Soft Tissue
  • Dental Implants
  • Healing Wound

Interventions

PROCEDURE

Bio-Oss Exposed

Molar extraction with a flapless approach and immediate implant installation, filling the gap with deproteinized bovine bone mineral (Geistlich Bio-Oss) and left exposed to the oral environment.

PROCEDURE

Mucograft Exposed

Molar extraction with a flapless approach and immediate implant installation, filling the gap with deproteinized bovine bone mineral (Bio-Oss; Geistlich) and covered by a collagen matrix (Mucograft; Geistlich).

Sponsors & Collaborators

  • São Paulo State University

    collaborator OTHER

  • Universidade Federal de Sergipe

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Valessa F Carvalho, PhD student · School of Dentistry of Ribeirão Preto

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2022-04-14
Completion
2022-06-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06191510 on ClinicalTrials.gov