Early Loading of Dental Implants; A Prospective Study in the Mandibular First Molar Area.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Loading of Dental Implants; A Prospective Study in the Mandibular First

Conditions
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Dental Implants

Intervention / Treatment
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* Device: Dental Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older. Willingness to comply with all study requirements. Partially edentulous in the in mandibular first molar with presence of the mandibular second molar Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias. Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion. Sufficient alveolar bone volume at the implant recipient site at the time of the insertion. 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: Pregnant or lactating females. Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus. History of irradiation in the head and neck area. Smoking. Untreated periodontitis. Alcohol or drug abuse. History of Intravenous Bisphosphonate. Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months. The use of regenerative procedures in conjunction with implant placement. Presence of residual roots at the implant recipient site. Stomatological diseases. Clinical signs of bruxism. Initial stability at least 35Ncm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loading of Dental Implants after 4 weeks<br>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<br>* Dental implant<br>|
| Active Comparator: Loading of Dental Implants after 3 months<br>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<br>* Dental implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marginal bone level changes by using periodical radiography. | 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) | assessment of marginal bone level (MBL) will be made at the time of implant placement and after 6 months |