The Role of Immediate Provisional Restorations on Bone Level Implants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00906165
First received: May 19, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone Level Implant 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.


Condition Intervention
Jaw, Edentulous, Partially
Device: Straumann® Bone Level SLActive Implant (4.1mm diameter)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Role of Immediate Provisional Restorations on Bone Level Implants. A Randomised, Single Blind Controlled Clinical Trial

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Success and Survival rate of the implants [ Time Frame: 1 year and 2 years after implant placement and at 1,3,5 years for patients who consented to extended follow up (up to 5 years post implant placement) ] [ Designated as safety issue: No ]
    The success and survival rate of the implants is presented as a cumulative survival rate and cumulative success rate at 1 year and 2 years post-implant placement, or at 1 year, 3years and 5 years post implant placement for patients who consent to participate in the extension period. (The Study was extended from 2-year follow-up to 5-year follow-up).

  • Complication rate (adverse events and/or implant failure) of the implants and implant overstructure [ Time Frame: 1 year and 2 years after implant placement and at 3,4,5 years after implant placement for patients who consent to participate in the extension period ] [ Designated as safety issue: No ]
    The study was extended to follow-up patient outcomes up to five years post-implant placement.

  • Probing Pocket Depth [ Time Frame: Recorded at 16 weeks, 6 months, 12 months, 24 months after implant placement and at 36 months, 48 months, 60 months post implant placement for patients consenting to participate in the extension period ] [ Designated as safety issue: No ]
    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.

  • Gingival Recessions (REC) [ Time Frame: Recorded at 16 weeks, 6 months, 12 months, 24 months after implant placement and at 36 months, 48 months and 60 months post implant placement for patients consenting to participation in the extension period ] [ Designated as safety issue: No ]
    The gingival recessions around the implants are recorded at the above-specified timepoints after implant placement, using a UNC-15 probe

  • Soft tissue changes [ Time Frame: Recorded at 16 weeks, 6 months, 12 months, 24 months after implant placement and at 36 months, 48 months, 60 months post implant placement for patients consenting to participation in the extension period ] [ Designated as safety issue: No ]
    Soft tissue changes: mesial and distal gingival papilla dimensions assessed by Papilla Fill Index (Jemt 1997) and the Pink Aesthetic Score (Furhauser 2005) will be recorded at the post-implant placement timepoints specified above.

  • Adverse Events [ Time Frame: From randomization to 5 years after implant placement ] [ Designated as safety issue: Yes ]
    Adverse Events and Serious Adverse Events will be assessed and followed up throughout the study duration


Estimated Enrollment: 24
Study Start Date: June 2008
Estimated Study Completion Date: November 2014
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1- Immediately provisionalized: Straumann Bone Level implant
The Straumann Bone Level SLActive implants (4.1mm diameter) will be immediately provisionalized upon placement. ie. impressions will be taken directly after implant installation in order to fabricate screw-retained resin crowns within 48 hours after implant placement. After 16 weeks the final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration.
Device: Straumann® Bone Level SLActive Implant (4.1mm diameter)
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 restorations).
Active Comparator: 2- Delayed Loading: Straumann Bone Level implant
The Straumann Bone Level SLActive implants (4.1mm diameter) will not be immediately provisionalized in this arm, instead there will be delayed implant loading. ie. 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. The final prosthetic reconstruction will be performed according to the standard procedure for single crowns after 16 weeks.
Device: Straumann® Bone Level SLActive Implant (4.1mm diameter)
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 restorations).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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.
    • 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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906165

Locations
United Kingdom
Eastman Dental Institute, University College London
London, United Kingdom, WC1X8LD
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Nikos Donos, Prof. Dr. Eastman Dental Institute
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00906165     History of Changes
Other Study ID Numbers: CR 05/07
Study First Received: May 19, 2009
Last Updated: August 5, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on September 16, 2014