K08.1
Conditions
Interventions
Group 1: Socket Preservation with OCS-B Collagen
Group 2: Socket Preservation with OCS-B Collagen w/ autologous wound cover (Tissue Punch or PRF membrane)
Group 3: Untreated and uncovered socket (Cont
Sponsors
NIBEC Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Patient has signed informed consent to participate in the study. • Requiring extraction of a single non-molar tooth with existing adjacent teeth that are to be retained • Teeth with intact alveolar bone walls • The subject must be in good physical and mental condition • The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures). • Full-mouth bleeding score (FMBS) lower than 25%. • Full-mouth plaque score (FMPI) lower than 25%. • The subject is suitable for a 2-stage surgical procedure
Exclusion criteria
Exclusion criteria: • Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure. • Multiple adjacent tooth extractions planned will be excluded • Dental implant adjacent to tooth planned for extraction • Mandibular incisor teeth and all molar teeth will be excluded. • Orthodontic tooth movement into the planned extraction site. • Dehiscence of the alveolar bone of more than 3 mm that can be detected pre-operatively using probing or bone sounding, as well as those that can be clinically detected immediately after tooth extraction will be excluded from this study. • Any disorders directly in the planned implant area such as previous tumors, chronic bone disedisease. • Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc). • Alcohol or drug abuse as noted in subject records or in subject history. • Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history. • Heavy smoking (> 10 cigarettes per day). • Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8% • Poor compliance. • Active periodontal disease involving the residual dentition, and Periodontitis which has led to more than 3 mm of attachment loss. • Mucosal diseases in the areas to be treated. • Pregnant or lactating women at the time of socket preservation procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Performance Evaluation: Evaluation of safety measures via occurrence of (S)AE ((serious) adverse events), DD (device deficiency) and medical device related events Bone gain 6 months after socket preservation procedure for implant placement. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Implant survival 2. Implant success 3. Overall Bone regeneration 4. Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non-bone components 5. Soft tissue outcome (Furhauser Pink Esthetic Score, PES). 6. oral health related quality of life assessment 7. Pain (VAS) | — |
Countries
Germany
Contacts
Public ContactShahram Ghanaati
Universtätsklinikum der Goethe Universität Frankfurt/Main, Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie
Outcome results
None listed