Dental Implants Clinical Trial
Official title:
Effect of Healing Xenogenic Biomaterial Exposed to the Oral Environment in Humans
Verified date | January 2024 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | June 15, 2022 |
Est. primary completion date | October 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Healthy adults (=18 years-old) exhibiting good oral hygiene, - Hopeless molar teeth with an intact buccal socket wall, - Sufficient apical bone allowing for immediate implant placement. Exclusion Criteria: - Individuals with systemic diseases that are unstable, - Uncontrolled metabolic conditions, - Daily smoking habit of =10 cigarettes, - Those who have received antibiotic drugs or corticosteroids within the past 3 months, or are currently on medications that impact bone healing, such as bisphosphonates, - Patients with a past history of chemotherapy or radiation therapy in the oral and maxillofacial region. |
Country | Name | City | State |
---|---|---|---|
Brazil | School of Dentistry of Ribeirão Preto - University of Sao Paulo | Ribeirão Preto | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | São Paulo State University, Universidade Federal de Sergipe |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Assessment of Epithelialization | Clinical measurements were recorded at 2 day, 1 week, and 1 month postoperatively and assessed as scores of epithelialization, graded as follows:
Grade 1: non-existent Grade 2: covering less than one-quarter of the wound surface Grade 3: covering less than half the wound surface Grade 4: covering more than three-quarters of the wound surface Grade 5: normal or complete covering of the wound. |
1 day, 1 week, 2 weeks, and 1 month after the implant placement | |
Other | Serum levels of cytokines | The cytokine content of each sample (evaluated on days 02, 07, 30 days of healing) was measured by multiplex assay. The cytokines analyzed were VEGF, IL-1ß and FGF2. | 2 day, 1 week, and 1 month after the implant placement | |
Primary | Keratinized Mucosa Width | The keratinized mucosa width was evaluated using a periodontal probe at the facial level before extraction and after 4 months at the implant placement. | before extraction; after 4 months | |
Secondary | Cone Beam Computed Tomographs Measurements | To assess in tooth, prior to extraction, mucosal thickness and changes in alveolar ridge height and width, a cone beam computed tomographs (CBCT) images were obtained under consistent conditions. All radiographic measurements and analyses were conducted both at baseline (after the implant placement) and after 4 months. | Baseline; after 4 months |
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