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MicrobiotaPiMicrobiomeNCT05941663

Microbiome Development in the Early Healing of Osseointegrated Implants

A study testing Dental implant surface in people with Microbiota and Dental Implants, run by Universidad Complutense de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Microbiota, Dental Implants
What is being tested?
Dental implant surface
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
28 Jan 2023to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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 with the healing process of either bone or soft tissue or the osseointegration process (e.g. bone metabolism disturbances, uncontrolled diabetes mellitus, anticoagulation drugs/ hemorrhagic diatheses)
  • Patients with local factors that could interfere with the healing process, such as untreated periodontal diseases, acute infection of implant site, temporomandibular joint disorders, treatable pathologic diseases of the jaw and changes in the oral mucosa)
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Faculty of Dentistry, University Complutense of Madrid (UCM)

    Madrid, 28040

Other trials in Spain

About this study

Official title: Microbiome Development in the Early Healing of Osseointegrated Implants. Impact of Surface Composition (SLActive® vs. SLA® Surface)

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.

Being tested
Dental implant surface

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental implant surfaceOther

    Implants provided were Bone Level Tapered (Bone Level Tapered) Roxolid® implants with a SLActive® or SLActive® surface

Study groups in NCT05941663
Study groupRoleWhat they receive
SLAactiveExperimentalImplants provided were Bone Level Tapered (Bone Level Tapered) Roxolid® implants with a SLActive® surface
Receives: Other: Dental implant surface
SLAActive comparatorImplants provided were Bone Level Tapered (Bone Level Tapered) Roxolid® implants with a SLA® surface
Receives: Other: Dental implant surface

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiome composition

    Samples will be processed by sequencing the 16S rRNA gene V3-V4 hypervariable region using MiSeq (Illumina, CA)

    Measured: 2 years

Secondary outcomes (3)

  1. 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.

    Measured: 2 years

  2. 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

    Measured: 2 years

  3. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start28 Jan 2023
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Split mouth design
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941663
Sponsor's protocol ID
URI 104-210623
Acronym
PiMicrobiome
Status last verified
May 2024
First submitted
3 Jul 2023
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Dental implant surface in people with Microbiota and Dental Implants, run by Universidad Complutense de Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiome composition (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05941663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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