Short Implants in Edentulous Mandible

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04838184
• Other study ID #: PV_4805
• Status: Active, not recruiting
• Start date: April 19, 2015
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous
• Mouth, Edentulous
• Tooth Loss

Intervention

Device:
• Dental 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Straumann AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival of implants and suprastructure. Measure: survival rates	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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