Short Implants in Edentulous Mandible

Study Overview
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Brief Summary
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Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years.

Detailed Description
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It is hypothesized that survival rates after 1, 3, and 5 years of Straumann Roxolid® / SLActive® 4 mm short implants do not differ from values of Straumann SLActive implants with more than 4 mm length in the same clinical situation.

Official Title
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Prospective Clinical Study of Straumann Roxolid®/SLactive® Short Implants in Edentulous Mandible

Conditions
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Tooth Loss, Edentulous Jaw

Intervention / Treatment
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* Device: Dental Implants (Straumann Roxolid® / SLActive®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General criteria: Age: 18 to 70 Edentulous mandible with reduced bone level in the posterior region (> 5 mm and < 8 mm above nerve conduit) Physical and mental condition that allow surgery and a 5-year follow-up period to be carried out without foreseeable problems Obtained informed consent from the patient Specific criteria: Limited vertical space for implant placement, where conventional implants with lengths of more than 4 mm cannot be used Tooth loss or extraction at least 8 weeks before implant surgery Healthy implantation site Favorable and stable occlusal relationship Complete denture in the mandible. If no denture available, an interims prosthesis will be fitted Natural full dentition or sufficient complete or partial dentures in the maxilla Exclusion Criteria: General criteria: Any conditions or circumstances which would interfere with the requirements for oral surgery Allergy to any metallic implant component Acute, untreated periodontitis Previous oro-maxillo-facial radiotherapy Any disorders in the planned implant area such as previous tumors or chronic bone disease (e.g., rheumatoid disease) Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.) Alcohol or drug abuse Heavy smoking (>10 cigarettes/day) Uncontrolled diabetes Severe bruxism or other destructive oral habits Pregnant or lactating women Specific criteria: Need for a major bone regeneration technique Infections in adjacent tissue of the planned implantation site. Bleeding on probing (BOP) and plaque index (PI) higher 25% Insufficient bone volume in the posterior region for placing a Straumann Roxolid® / SLActive® 4mm short implant and in the interforaminal region for placing a Straumann Roxolid® / SLActive® implant with a minimum length of 10 mm determined by radiographic analysis (OPG)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dental patients<br>Patients with an edentulous mandible who are demanding and receiving an implant-supported fixed dental prosthesis in the mandible | Device: Dental Implants (Straumann Roxolid® / SLActive®)<br>* In this study the 4 mm implants will be inserted in the area surrounding 36/46. The implant diameters will be defined based on the patient's situation. In the interforaminal region, two implants of conventional length with a minimum of 10 mm will be inserted. The implant diameter and the length will be defined based on the patient's situation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival of implants and suprastructure. Measure: survival rates | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | Within-subject comparison of primary (at implant placement) and secondary (at implant exposure) stability of short versus regular length implants. Measure / device: Resonance Frequency Analysis (RFA) | 3 months | 
| Success | Success of implants and suprastructure. Measure: success rates Biological success: No detectable clinical mobility (hand testing) No radiolucency surrounding the total surface of the implant No persistent pain refractory to medical therapy No recurrent peri-implant infection Peri-implant infection: peri-implant Probing Depth (PD), Plaque Index (Pl), and Bleeding on Probing (BoP) Bone loss: standardized intra-oral radiography with long-cone parallel technique Technical success: No screw loosening No fracture of metal base No fracture of veneering material | 5 years | 
| Oral health-related quality of life | Oral health-related quality of life (OHRQoL). Measure: questionnaire - 49-item Oral Health Impact Profile (OHIP) with a 5-point ordinal rating scale (possible range of summary scores: 0-196 with higher scores indicating more impairment) | 5 years | 
| Patient satisfaction | Patient satisfaction. Measure: questionnaire - Visual analogue scales (VAS) on ease of cleaning, speech, comfort, esthetic, stability, chewing ability, masticatory function, and oral health (possible range of scores: 0-10 for each item with higher scores indicating more satisfaction) | 5 years |