Missing Several TeethSTRANDINCT01620918

Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.

A study testing normal healing abutment and nano-structured healing abutment in people with Missing Several Teeth and Minimum of 2 Dental Implants Needed, run by University Ghent at 1 site in Belgium.

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

Baseline: Standard preparation of the osteotomy Placement of 2 dental implants On each implant one of both types of healing abutments is placed Suturing Standardized radiography to measure bone-levels at baseline Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Missing Several Teeth, Minimum of 2 Dental Implants Needed
What is being tested?: normal healing abutment and nano-structured healing abutment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteBelgium
Study dates: Aug 2012to Aug 2015
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

Patients are eligible for this study if they are in need of minimum 2 dental implants and have sufficient bone to place these implants

Who cannot join

All patients with limited bone
Periodontally compromised patients
Patients who took antibiotics 3 months before implantation
Patients with uncontrolled diabetes
Pregnant patients
Patients who received radiotherapy in the head/neck region
Patients under chemotherapy
Patients who had intravenous use of bisphosphonates

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Ghent University
Ghent, 9000

Other trials in Belgium

About this study

Baseline:
Standard preparation of the osteotomy
Placement of 2 dental implants
On each implant one of both types of healing abutments is placed
Suturing
Standardized radiography to measure bone-levels at baseline
Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to measure the baseline level of the gingiva
2 weeks after Baseline:
Removal of the sutures
4 weeks after Baseline:
A 2nd digital impression of the soft tissue with an intra-oral scanner
Collecting crevicular fluid by placing paperpoints in the provided apertures in the healing abutments for 60 seconds without bleeding.
Measuring of the pocket depth in the provided apertures in the healing abutments with an automated probe.
Removal of the Healing Abutment with the attached soft tissue en-bloque.
Placement of a new, regular, Encode Healing Abutment.
10 weeks after Baseline:
Start of standard prosthetic procedure. In this study we expect that the soft tissue attachment (i.e. the gingival attachment) will be stronger and earlier achieved at the nano-structured healing abutments than at the normal, uncoated healing abutments. This would lead to a more stable soft tissue complex on the long rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger attachment would mean a stronger barrier against micro-organisms and might influence the occurrence of peri-implantitis.

Conditions: Missing Several Teeth, Minimum of 2 Dental Implants Needed
Being tested: normal healing abutment, nano-structured healing abutment

What participants receive

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

normal healing abutmentProcedure or surgery
Patient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.
nano-structured healing abutmentProcedure or surgery
Patient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.

Study groups in NCT01620918
Study group	Role	What they receive
2 types of healing abutment	Experimental	Patients who are in need of minimal 2 dental implants, who will receive both types of healing abutments. Receives: Procedure: normal healing abutment; Procedure: nano-structured healing abutment

What is being measured

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

The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation.
Genetic evaluation (through Polymerase Chain Reaction, PCR, the tissue will be detected for certain growth factors), histomorphometric analysis to measure the actual percentage of the surface on which the gingiva is attached to, clinical evaluation of the strength of the attachment through means of an automated probe.
Measured: at 4 weeks post-implantation

Timeline

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

Aug 2012Aug 2015

First posted15 Jun 2012 (estimated)
Study startAug 2012
Primary completionJan 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Missing Several TeethStudies of the same condition, open and under way.
More trials run by University GhentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01620918
Sponsor's protocol ID: 2012/341
Acronym: STRANDI
Status last verified: Nov 2021
First submitted: 13 Jun 2012
Last updated: 1 Dec 2021
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.
ClinicalTrials.gov ID: NCT01620918
Acronym / sponsor ID: STRANDI / 2012/341
Conditions: Missing Several Teeth, Minimum of 2 Dental Implants Needed
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University GhentUniversity, hospital or other
Study start: Aug 2012 (actual)
Primary completion: Jan 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 15 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Baseline:
Standard preparation of the osteotomy
Placement of 2 dental implants
On each implant one of both types of healing abutments is placed
Suturing
Standardized radiography to measure bone-levels at baseline
Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to measure the baseline level of the gingiva
2 weeks after Baseline:
Removal of the sutures
4 weeks after Baseline:
A 2nd digital impression of the soft tissue with an intra-oral scanner
Collecting crevicular fluid by placing paperpoints in the provided apertures in the healing abutments for 60 seconds without bleeding.
Measuring of the pocket depth in the provided apertures in the healing abutments with an automated probe.
Removal of the Healing Abutment with the attached soft tissue en-bloque.
Placement of a new, regular, Encode Healing Abutment.
10 weeks after Baseline:
Start of standard prosthetic procedure. In this study we expect that the soft tissue attachment (i.e. the gingival attachment) will be stronger and earlier achieved at the nano-structured healing abutments than at the normal, uncoated healing abutments. This would lead to a more stable soft tissue complex on the long rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger attachment would mean a stronger barrier against micro-organisms and might influence the occurrence of peri-implantitis.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
2 types of healing abutment	Experimental	Procedure: normal healing abutment, Procedure: nano-structured healing abutmentPatients who are in need of minimal 2 dental implants, who will receive both types of healing abutments.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients are eligible for this study if they are in need of minimum 2 dental implants and have sufficient bone to place these implants

Key exclusion criteria (8 listed)

All patients with limited bone
Periodontally compromised patients
Patients who took antibiotics 3 months before implantation
Patients with uncontrolled diabetes
Pregnant patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
normal healing abutmentPatient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.	Procedure or surgery	2 types of healing abutment
nano-structured healing abutmentPatient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.	Procedure or surgery	2 types of healing abutment

Primary outcome

The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation.
Time frame: at 4 weeks post-implantation
Genetic evaluation (through Polymerase Chain Reaction, PCR, the tissue will be detected for certain growth factors), histomorphometric analysis to measure the actual percentage of the surface on which the gingiva is attached to, clinical evaluation of the strength of the attachment through means of an automated probe.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hugo De Bruyn, DDS, MSc, PhD principal investigator

University Ghent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 8 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 1 Dec 2021. 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 Belgium. 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?

The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation. (time frame: at 4 weeks post-implantation). 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 NCT01620918.

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 1 Dec 2021.