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NCT05941663: PiMicrobiome
Microbiome Development in the Early Healing of Osseointegrated Implants
NA trial testing Dental implant surface in Microbiota in 30 participants. Completed in 30 June 2023.
30 June 2023
Quick facts
| Lead sponsor | Universidad Complutense de Madrid |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 28 January 2023 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Dental implant surface
Conditions studied
- Microbiota — all drugs for Microbiota →
- Dental Implants — all drugs for Dental Implants →
Sponsor
Universidad Complutense de Madrid — full company profile →
Who can join
18 and older, any sex, with Microbiota or Dental Implants. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
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 NCT05941663
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05941663 (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 Universidad Complutense de Madrid
- Last refreshed: 9 May 2024
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/NCT05941663.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing