Microbiome Development in the Early Healing of Osseointegrated Implants (NCT05941663) | Clinical Trial Compass
CompletedNot Applicable
Microbiome Development in the Early Healing of Osseointegrated Implants
Spain30 participantsStarted 2023-01-28
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females, at least 18 years old
* Partially edentulous patients rehabilitated with at least two dental implants (canine to molars) placed in two different quadrants in healed sites (3 months post extraction) as part of the previous RCT.
* Subject must have voluntarily signed the informed consent, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed.
For the current investigation, only those participants treated in the University Complutense of Madrid (n=30) will be selected
Exclusion Criteria:
* Any contraindications for oral surgical procedures
* Dental implant placement contraindicated according to Instructions for Use (IFU)
* Subjects with inadequate oral hygiene (FMPS ≥ 20%)
* Subjects who are currently heavy smokers (defined \>10 cigarettes per day or \>1 cigar per day) or who use chewing tobacco
* Subjects with drug or alcohol abuse
* Patients requiring soft tissue and bone grafting procedures
* Patients having had soft tissue grafting procedures within the last 3 months and bone grafting procedures within the last 6 months in the region where a study implant is planned
* Keratinized soft tissue height of less than 2 mm where a study implant is planned
* Inadequate bone volume
* Severe bruxism or clenching habits
* Woman who are pregnant or planning to become pregnant at any point during the study duration.
* Patients who have systemic factors that could interfere wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.