Phase 4
N=280
Evaluation of Immediate Versus Delayed Loading of Dental Implants With a Modified Surface
Partial Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT00782171 ↗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
| Outcome | Result | p-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
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.