The Role of Immediate Provisional Restorations on Bone Level Implants

NCT00906165 | Completed Results

• 1 other identifier: CR 05/07
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. In both cases the implants will be loaded at 16 weeks (final restorations). The outcomes will be evaluated over a 2-year period.

Conditions

Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (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.

  between baseline and one year post treatment

Secondary Outcomes (7)

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

  1 year and 2 years after implant placement

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

  2 years after implant placement

• Probing Pocket Depth

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

• Gingival Recessions (REC)

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

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

  Recorded at 12 and 24 months after implant placement

Study Arms (2)

1- Immediately provisionalized

ACTIVE COMPARATOR

The 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.

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

2- Delayed Loading

ACTIVE COMPARATOR

The 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.

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

Interventions

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)

1- Immediately provisionalized; 2- Delayed Loading

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (1)

Eastman Dental Institute, University College London

London, WC1X8LD, United Kingdom

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Professor N Donos
• Organization: UCL Eastman Dental lnstitute University College London

n.donos@eastman.ucl.ac.uk

+4420 3456 1075

Study Officials

• Nikos Donos, Prof. Dr.

  Eastman Dental Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: June 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2016
• Last Updated: March 15, 2019
• Results First Posted: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)