Early Loading of Dental Implants; A Prospective Study in the Mandibular First Molar Area.
Study Details
Study Description
Brief Summary
To evaluate the clinical success, stability, radiographic bone level changes and peri-implants soft tissue parameter of the SLActive surface implant supporting single crowns restorations in early loading in the mandibular first molar region.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The human clinical trial will be designed as a longitudinal prospective study. A total of 24 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar. 12 for the control group and for the 12 test group.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Loading of Dental Implants after 4 weeks A total of 12 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar. for this group. After 4 weeks definitive crown will be placed. |
Device: Dental Implant
Dental implant
|
| Active Comparator: Loading of Dental Implants after 3 months A total of 12 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar for this group. After 3 months definitive crown will be placed |
Device: Dental Implant
Dental implant
|
Outcome Measures
Primary Outcome Measures
- marginal bone level changes by using periodical radiography. [assessment of marginal bone level (MBL) will be made at the time of implant placement and after 6 months]
Standardized radiographs using customized jig and long cone paralleling technique, using Rinn Film holders (Dentsply, Germany) for assessment of marginal bone level (MBL) will be made at the time of implant placement, as well as at 3 and 6 months 3. Changes in interproximal crestal bone levels will be measured and recorded using NIH Image Program Software(http:/rsb.info.nih.gov/nih-image)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 18 years or older.
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Willingness to comply with all study requirements.
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Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
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Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
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Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
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Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
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Adequate oral hygiene. Full-mouth plaque score (FMPS) (O'Leary et al. 1972) full-mouth bleeding score (FMBS) (Ainamo & Bay 1975) record as the percentage of surfaces, four per each tooth, patients need to have controlled their periodontal conditions (FMPS 20%, FMBS 20%).
Exclusion Criteria:
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Pregnant or lactating females.
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Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
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History of irradiation in the head and neck area.
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Smoking.
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Untreated periodontitis.
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Alcohol or drug abuse.
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History of Intravenous Bisphosphonate.
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Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
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The use of regenerative procedures in conjunction with implant placement.
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Presence of residual roots at the implant recipient site.
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Stomatological diseases.
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Clinical signs of bruxism.
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Initial stability at least 35Ncm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda Health | Loma Linda | California | United States | 92350 |
Sponsors and Collaborators
- Loma Linda University
Investigators
- Principal Investigator: Aladdin j Alardah, DDS, associate professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5160039