An interventional study of Dental implant surface in Microbiota and Dental Implants, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
The aim is to compare the microbiome composition on the first month of healing and 2 years after rehabilitation in two different implant surfaces (SLA® vs SLActive®). Subjects in need of two or more dental implants (canine to molars) in two different quadrants will be included so that, one study test (SLActive®) and one study control (SLA®) implant will be placed in different quadrants in healed extraction sites. Gingival crevicular fluid (GCF) samples will be taken for microbiome analysis at different time points. Samples will be processed using high throughput sequencing technologies (Illumina® MiSeq) and the raw sequencing reads will be processed with the Quantitative Insights Into Microbial Ecology (QIIME2) pipeline. DADA2 will be used for quality trimming and inferring amplicon sequence variants (ASVs). Taxonomy will be assigned to ASVs using the Naive Bayesian Classifier integrated in QIIME2 plugins and the eHOMD RefSeq database. Alpha-diversity and Beta diversity will be calculated and measured. Differences in bacterial abundance will be analyzed using linear models for differential abundance analysis (LinDA).
This is the long-term follow-up of the randomized clinical trial entitled "Randomized controlled study to evaluate the clinical behavior of dental implants with SLActive® surface vs. SLA® surface" Promoter Code: CR 2017-05, Internal Code: 18/580-R_P, Promoter: Institute Straumann AG. In this new protocol, the participants included in the clinical trial at the Complutense University of Madrid will be selected, who will undergo a new follow-up visit at 2 years, to measure the clinical, radiographic and microbiological situation. periodontal treatment without any additional intervention. In addition, it is intended to analyze the microbiome of the samples of gingival crevicular fluid that we have frozen from the patients of the UCM, as well as of the samples that are taken after two years. All these changes are promoted by our ETEP (Etiology and Therapeutics of Periodontal and Peri-implant Diseases) research group, independently of the original sponsor of the study.
Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the current investigation, only those participants treated in the University Complutense of Madrid (n=30) will be selected
Exclusion Criteria:
Patients will be informed verbally and in written paper of the visit at 2-year post-implant placement, and will need to sign a new informed consent for this evaluation.
Implants provided were Bone Level Tapered (Bone Level Tapered) Roxolid® implants with a SLActive® surface
Other: Dental implant surface
Implants provided were Bone Level Tapered (Bone Level Tapered) Roxolid® implants with a SLA® surface
Other: Dental implant surface
Implants provided were Bone Level Tapered (Bone Level Tapered) Roxolid® implants with a SLActive® or SLActive® surface
Microbiome composition
Samples will be processed by sequencing the 16S rRNA gene V3-V4 hypervariable region using MiSeq (Illumina, CA)
Time frame: 2 years
Radiographic measurements
The reference point for the bone level measurement is the implant shoulder. The bone level will be measured as the distance between the implant shoulder and the first visible bone contact on the implant. The bone level will be measured on the mesial and distal aspect of the 2 study implants. Mean bone level changes between two time-points will be computed by subtracting the average bone level from one visit with the other.
Time frame: 2 years
Peri-implant diseases incidence
A full periodontal chart will be recorded of each patient at visit 10 (2 years after implant placement). Probing pocket depth, recession, bleeding on probing, plaque presence on 6 sites per tooth/implant will be registered (mesial, medial and distal, at buccal and lingual sides). This will be performed with a North Carolina Periodontal Probe and values will be given in millimeters
Time frame: 2 years
Questionnaire of oral care
A questionnaire about the maintenance and oral care that the patient has followed during the last 2 years will be recorded in order to better understand the information obtained from clinical, radiographical and microbiological parameters. The following questions will be asked: (1) Did you receive periodontal maintenance care in the last 6 months? (2) How many appointments for maintenance care have you accomplished in the last 2 years? (3) Do you use interproximal devices for your everyday oral care? (4) Did you received peri-implant or periodontal non-surgical therapy in the last 2 years? And surgical? This information will be completed by searching in the individual history of the data recording system of the university.
Time frame: 2 years
Plan to share: Undecided
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Universidad Complutense de Madrid