Edentulous Jaw, Tooth Loss
Conditions
Brief summary
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
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.
Interventions
DEVICEDental Implants (Straumann Roxolid® / SLActive®)
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.
Sponsors
Straumann AG
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 5 years | Survival of implants and suprastructure. Measure: survival rates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant stability | 3 months | 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) |
| Success | 5 years | 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 |
| Oral health-related quality of life | 5 years | 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) |
| Patient satisfaction | 5 years | 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) |
Outcome results
None listed