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Phase 4 N=280 Randomized Treatment

Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface

Partial Edentulism

Enrolled (actual)
280
Serious AEs
1.1%
Results posted
Jun 2017
Primary outcome: Primary: Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group. — 0.82; 0.56 mm

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
SLActive dental implant (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Institut Straumann AG
Primary completion
Oct 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
0.88; 0.57
PRIMARY
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
0.88; 0.57
PRIMARY
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
0.88; 0.57
PRIMARY
Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.
0.88; 0.57
SECONDARY
Implant Survival
192; 180
SECONDARY
Implant Survival
192; 180
SECONDARY
Implant Survival
192; 180
SECONDARY
Implant Survival
192; 180
SECONDARY
Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected
38; 35; 20; 15
SECONDARY
Implant Success
174; 164
SECONDARY
Implant Success
174; 164
SECONDARY
Implant Success
174; 164
SECONDARY
Implant Success
174; 164
SECONDARY
Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events
56; 41; 26; 17; 0; 0

Summary

The purpose of this study is to evaluate the performance of a new dental implant with a modified surface in different loading protocols.

Eligibility Criteria

Inclusion Criteria

  • Males and females must be at least 18 years of age
  • Have at least one missing tooth in positions FDI 4, 5, 6, or 7 in any quadrant (ADA positions 2, 3, 4, 5; or 12, 13, 14, 15; or 20, 21, 22, 23; or 28, 29, 30, 31.)
  • Subjects desire an implant supported restoration on1 to 4 implants per quadrant
  • The tooth/teeth position(s) at the proposed implant site must have been extracted or lost at least 4 months before the date of implantation and be fully healed
  • Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann standard 4.1 mm diameter implant of at least 8 mm length without the use of concurrent bone augmentation techniques. If more bone is available and is indicated a Straumann standard 4.8 mm diameter implant with a wide neck of at least 8 mm length may be used, i.e. implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm of bone lingual and buccal bone will remain
  • The opposing dentition must be natural teeth or fixed crowns or bridges on natural teeth or implants. Removable prostheses or dentures opposing the study implants are not allowed
  • Patients must be committed to the study for its full duration.

Exclusion Criteria

  • Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
  • Medical conditions requiring prolonged use of steroids
  • History of leukocyte dysfunction and deficiencies
  • History of bleeding disorders
  • History of neoplastic disease requiring the use of chemotherapy
  • History of radiation therapy to the head and neck
  • Patients with history of renal failure
  • Patients with severe or uncontrolled metabolic bone disorders
  • Uncontrolled endocrine disorders
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0
  • Alcoholism or drug abuse
  • Patients infected with HIV
  • Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew tobacco
  • 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
  • Local inflammation, including untreated periodontitis
  • Mucosal diseases such as erosive lichen planus
  • History of local irradiation therapy
  • Presence of osseous lesions
  • Unhealed extraction sites (less than 4 months post extraction of teeth in intended sites)
  • Bone surgery (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement and the site fully healed. Note: Minor bone enhancement using harvested bone from the implant site and a resorbable membrane is allowed at the time of implant placement
  • Patients requiring bone grafting at the surgical sites at the time of surgery.
  • Severe bruxing or clenching habits
  • Persistent intraoral infection
  • Lack of primary stability of one (or more) implant(s) at surgery. In this instance the patient must be withdrawn and the patient treated accordingly
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00782171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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