K08.1
Conditions
Interventions
Group 1: Control group = no further treatment post tooth extraction (unfilled and untreated socket), wound is left to natural healing, 3 months post-extraction implantation of dental implant
Group 2:
Sponsors
NIBEC Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Subjects between 18 and 65 years old. • Patient has signed informed consent to participate in the study. • Requiring extraction of a single tooth • The subject must be in good physical and mental condition • The subject must have a good oral hygienic status, full mouth plaque score </=25% • The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene ?and attending all follow-up procedures).
Exclusion criteria
Exclusion criteria: • Severe systemic disease • Smoking • Alcohol or substance abuse • History of / or active periodontal disease involving the residual dentition • Untreated caries lesions • Acute abscess • Pregnant or nursing • Involvement in another clinical trial that may interfere with the outcomes of this study • Not willing or unable to provide consent • Not willing or unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Soft Tissue Healing, evaluated by residual wound size at 10 days post-extraction, analyzed via semi-quantitative image analysis of clinical photodocumentation 2. Lateral Bone Gain, evaluated as bone gain or bone loss 3 months post-extraction compared to post-extraction, analysis via distance measurement between alveolar bone and cement-enamel-junction (CEJ) in clinical radiological images | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain perception post-surgery (via visual analoge scale VAS) - Implant success - Implant stability - Implant survival - Quality of Life - Safety Endpoints (AE/SAE), complications and morbidities | — |
Countries
Germany, South Korea
Outcome results
None listed