Short Implants in Edentulous Mandible

• Conditions: Tooth Loss; Edentulous Jaw
• Interventions: Device: Dental Implants (Straumann Roxolid® / SLActive®)

• Registration Number: NCT04838184
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2015-04-19
• Status Verified: 2021-03
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-04-07
• Last Update Submitted: 2021-04-07
• Study First Posted: 2021-04-09
• Last Update Posted: 2021-04-09
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dental patients	Dental Implants (Straumann Roxolid® / SLActive®)	Patients with an edentulous mandible who are demanding and receiving an implant-supported fixed dental prosthesis in the mandible

Primary Outcome Measures

Name	Time	Method
Survival	5 years	Survival of implants and suprastructure. Measure: survival rates

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)