Single dental implant retained mandibular complete dentures – influence of the loading protocol

Not Applicable

• Conditions: Edentoulism

• Registration Number: DRKS00003730
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-23
• Study Completion: 2019-09-25
• Results First Posted: 2020-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

Edentulous patients in the age of 60-89 years without contraindication for implantation and sufficient bone in the anterior mandible to place an implant without augmentation procedures.
- Residual bone height is 11 to 20 mm (Type II and III according to McGarry et al.) at the least vertical height of the mandible and vertical bone height in the midline of the mandible is at least 13 mm.
- Despite technically acceptable complete dentures in mandible and maxilla the patient is unsatisfied with the retention and/or stability of the mandibular denture while the denture in the maxilla has adequate retention and stability.
- To allow adaptation existing dentures have been worn at least for 3 months. Dentures must have a bilaterally balanced occlusal scheme.

Exclusion Criteria

- Edentulous patients in the age of 60-89 years with contraindication for implantation in the mandible caused by systematic diseases or local bone deficits.
- Patients who are satisfied with the retention of their mandibular denture or who are unsatisfied with the retention and/or stability of their denture in the maxilla.
- Subjects with Symptom Check list-90- R(evised) (SCL-90-R, German version) index T-scores of 70 or greater or with two symptom scale scores of 70 or greater will be excluded from the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prim. Endpoint: Success of the single median implant according to the modified success criteria of Albrektsson et al. (criteria list) - clinical evaluation after 1, 4, 12, 24 and 60 months.

Secondary Outcome Measures

Name	Time	Method
Sec. endpoint: Pain and discomfort through the interventions - measured by a VAS questionnaire during the week after surgery intervention.<br>Sec. endpoint: Quality of life and chewing function - measured by a VAS questionnaire 1, 4, 12, 24 and 60 months after intervention.<br>Sec. endpoint: Chewing efficiency - measured clinically by the Swallowing Threshold Test Index and the objective masticatory performance 1, 4, 12, 24 and 60 months after intervention.<br>Sec. endpoint: Prosthetic complications - continuous documentation of complications over 60 months.<br>Sec. endpoint: Marginal bone loss - measured by comparison of radiographs taken directly after implant placement and 24 and 60 months after intervention.