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Jaw, Edentulous, PartiallyNCT00906165

The Role of Immediate Provisional Restorations on Bone Level Implants

A study testing Straumann® Bone Level SLActive Implant (4.1mm diameter) in people with Jaw, Edentulous, Partially, run by Institut Straumann AG at 1 site in United Kingdom.

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 study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and immediately provisionalised versus the same type of implants placed in healed alveolar ridge but not provisionalised. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Jaw, Edentulous, Partially
What is being tested?
Straumann® Bone Level SLActive Implant (4.1mm diameter)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited Kingdom
Study dates
Jun 2008to Apr 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion criteria
  • Males and females, age 18 to 75 years of age (the subjects should be legally able to give informed consent to the procedure; age limitation is also present to avoid inclusion of subjects with incomplete cranio-facial growth).
  • Absence of relevant medical conditions. Patients with contributing medical history in which any elective oral surgical intervention would be contraindicated should be excluded. In particular patients with uncontrolled or poorly controlled diabetes, or unstable or life threatening conditions should be excluded.
  • Absence of uncontrolled or untreated periodontal disease.
  • Absence of untreated caries lesions.
  • Patient in good medical and psychological health as documented by self assessment
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  • Patient's availability for follow-up according to the protocol.
  • Local inclusion criteria
  • A single tooth replacement is required in the incisor, canine, pre-molar and first molar region. Multiple-implant restorations (non adjacent to the test implant) can be performed during the study (not to be included as test implants).
  • at least 8 weeks post extraction where the soft tissues of the socket have healed
  • Presence of at least one adjacent tooth
  • Presence of adequate native bone to achieve primary stability

Who cannot join

  • General exclusion criteria
  • Patients who have any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation.
  • Female patients who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence).
  • Patients who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists, cyclosporine) within one month of baseline visit.
  • Patients who are on concomitant anticoagulant therapy of warfarin (coumadine), clopidogrel, ticlopidine or once daily aspirin of more than 81 mg.
  • Patients who knowingly have HIV or Hepatitis.
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  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
  • Patients who have undergone administration of any investigational drug within 30 days of study initiation.
  • Alcoholism or chronically drug abuse causing systemic compromisation.
  • Patients who are heavy smokers (>10/cigarettes per day).
  • Patients suffering from a known psychological disorder.
  • Patients who have limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained or simple instructions cannot be followed.
  • Exclude patients with BOP > 30% at the completion of the pre-treatment phase.
  • Local exclusion criteria
  • Exclude experimental sites with inadequate bone availability where initial stability of the implant cannot be achieved or extended augmentation procedures and/ or sinus nasal lift are required.
  • History of local radiation therapy.
  • Presence of severe oral lesions.
  • Severe bruxism or clenching habits
  • Patients with lack of posterior occlusion and severely reduced vertical dimension of occlusion
  • Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease in the implant area.
  • Patients presenting an acute endodontic lesion in the neighboring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible)
  • Plaque score > 30%

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Eastman Dental Institute, University College London

    London, WC1X8LD

Other trials in United Kingdom

About this study

Official title: The Role of Immediate Provisional Restorations on Bone Level Implants. A Randomised, Single Blind Controlled Clinical Trial

The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and immediately provisionalised versus the same type of implants placed in healed alveolar ridge but not provisionalised. In both cases the implants will be loaded at 16 weeks (final restorations). The outcomes will be evaluated over a 2-year period.

Read the detailed description

This is a prospective, randomised, controlled, single blind, and single center study. The total study duration for each patient should be 24 months.

Straumann Bone Level Ø 4.1 mm SLActive implants will be placed for single tooth replacement, followed by either immediate provisional prosthetic loading or no provisionalised. The final prosthetic loading is made at 16 weeks after implant loading. The implant length will be selected according to the clinical indication of the site based on previous radiographic evaluation.

In total 11 visits per patient are scheduled in this study. Bone level changes, implant success and survival rate, soft tissue changes, aesthetic outcome and adverse events (AEs) will be assessed.

The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products.

One center in the United Kingdom will participate.

Being tested
Straumann® Bone Level SLActive Implant (4.1mm diameter)
Medical subject headings
Jaw, Edentulous, Partially

What participants receive

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

  • Straumann® Bone Level SLActive Implant (4.1mm diameter)Device

    Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)

Study groups in NCT00906165
Study groupRoleWhat they receive
1- Immediately provisionalizedActive comparatorThe Straumann® Bone Level SLActive Implant (4.1mm diameter) will be immediately provisionalized upon placement, i.e. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.
Receives: Device: Straumann® Bone Level SLActive Implant (4.1mm diameter)
2- Delayed LoadingActive comparatorThe Straumann® Bone Level SLActive Implant (4.1mm diameter) will not be immediately provisionalized, instead there will be delayed implant loading. i.e. the patient will receive a removable prosthesis if necessary and the impressions for the final restoration will be taken 12-14 weeks after implant installation. At 16 weeks, the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.
Receives: Device: Straumann® Bone Level SLActive Implant (4.1mm diameter)

What is being measured

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

  1. Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment

    The primary parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements at baseline and one year after implant placement. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants, on digitized standardized peri-apical x-rays using an image analysis computer program.

    Measured: between baseline and one year post treatment

Secondary outcomes (7)

  1. Number of Participants With Survival Rate of the Implants at 12 and 24 Months

    The survival rate of the implants is presented as a cumulative survival rate at 1 year and 2 years post-implant placement.

    Measured: 1 year and 2 years after implant placement

  2. No. of Participants With Complications of the Implant and Implant Overstructure at 24 Months

    No of participants with prosthetic related complications and with implant failures are described after 24 months

    Measured: 2 years after implant placement

  3. Probing Pocket Depth

    The Probing Pocket Depth around the implants will be measured using a UNC-15 probe with light probing force (0.2N) at the post-implant time-points specified. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants)

    Measured: Recorded at 16 weeks, 6, 12, and 24 months after implant placement

  4. Gingival Recessions (REC)

    The gingival recessions around the implants are recorded at the above-specified timepoints after implant placement, using a UNC-15 probe. Differences between the Outcome Measure time points will be displayed. Baseline is 16 weeks (loading of implants)

    Measured: Recorded at 16 weeks, 6, 12 and 24 months after implant placement

  5. Number of Participants With Soft Tissue Changes Assessed by Papilla Fill Index

    Soft tissue changes: mesial and distal gingival papilla dimensions assessed by Papilla Fill Index (PFI, Jemt 1997) and the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above.

    Measured: Recorded at 12 and 24 months after implant placement

  6. Adverse Events

    Adverse Events (AE) and Serious Adverse Events (SAE) will be assessed and followed up throughout the study duration

    Measured: From randomization to 2 years after implant placement

  7. Soft Tissue Changes, Pink Aesthetic Score

    Soft tissue changes: the Pink Aesthetic Score (PES, Furhauser 2005) will be recorded at the post-implant placement timepoints specified above.

    The PES index includes assessment of seven variables and each variable is measured with a 2, 1, or 0 score with 2 being the best and 0 being the poorest score. Based on its definition the PES is a cumulative score with 14 being the best and 0 the worst.

    Measured: Recorded at 12 and 24 months after implant placement

Timeline

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

  1. First posted21 May 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionNov 2011
  4. Study completionApr 2016

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
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00906165
Sponsor's protocol ID
CR 05/07
Status last verified
Mar 2019
First submitted
19 May 2009
Last updated
15 Mar 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Straumann® Bone Level SLActive Implant (4.1mm diameter) in people with Jaw, Edentulous, Partially, run by Institut Straumann AG at 1 site in United Kingdom.

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 12 inclusion and 22 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 15 Mar 2019. 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 United Kingdom. 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?

Yes. Results are posted in the registry (first posted 15 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Radiographic Bone Level Change at the Mesial and Distal of the Implants Between Baseline and One Year Post Treatment (time frame: between baseline and one year post treatment). 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 NCT00906165.

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 15 Mar 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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