Tooth Loss
Conditions
Keywords
Dental Implants, Implant-Abutment Connection Types, Conical Connection, Butt-Joint Connection, Peri-Implant Soft Tissue, Digital Monitoring
Brief summary
Objectives: assessment of dimensional soft tissues change after single tooth gap implantation with a closed healing approach and using conical and butt-joint implant-abutment connection type. Material and Methods: forty patients were enrolled in the study and received randomly allocated implants with conical and butt-joint implant-abutment connection type. A standard healing abutment was placed after 6 months for two weeks. The definitive screw retained crowns were manufactured in a digital workflow. The soft tissue profile was digitized using IOS on following stages: pre-op, immediately, two, 7 and 14 days post-op, pre-exposure, immediately after exposure, two weeks after exposure (pre-delivery), immediately after crown delivery, 6 and 12 months after delivery. The intraoral scans were matched in the metrology software (Geomagic Control X). The mean maximum and mean average differences in mm were gathered to assess the soft tissues change. Various anamnesis parameters have been taken into account.
Interventions
DEVICEImplant Placement with Conical or Butt-Joint Connection
Thirty eight patients were enrolled in the study and received randomly allocated implants with conical and butt-joint implant-abutment connection type. A standard healing abutment was placed after 6 months for two weeks. The definitive screw retained crowns were manufactured in a digital workflow. The soft tissue profile was digitized using IOS on following stages: pre-op, post-op: immediately, two, 7 and 14 days, pre-exposure, immediately after exposure, two weeks after exposure (pre-delivery), immediately after crown delivery, 6 and 12 months post-op.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
In this study, the primary investigator was informed about the type of implant connection, while the second operator and the patients were not aware of the prosthetic material. No other parties are masked.
Intervention model description
Example: This study uses a parallel-group design, where patients are randomly assigned to either a group with conical connection or a group with butt-joint connection. Soft tissue changes are digitally monitored over a 12-month period.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of a single tooth gap, completion of conservative and periodontal treatments, diagnostic preoperative models, and a recent panoramic radiograph not older than 6 months.
Exclusion criteria
* Abnormal jaw anatomy, insufficient bone volume, bone conditions (e.g., cysts, tumors), oral mucosa abnormalities (e.g., lesions, diseases), untreated periodontal disease, acute inflammation, pregnancy, temporary medication contraindications, psychological issues (e.g., substance abuse), poor compliance, and general medical contraindications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear changes of soft tissue in mm | Assessment at pre-op, immediately post-op, 2 days, 7 days, 14 days, pre-exposure, post-exposure, pre-delivery, immediately after crown delivery, 6 months, and 12 months. | The primary outcome measure is the change in peri-implant soft tissue profile, quantified in millimeters, assessed at various stages post-op. This includes measurements taken at pre-operative, immediately post-operative, 2 days, 7 days, 14 days, pre-exposure, post-exposure, pre-delivery, immediately after crown delivery, and at 6 and 12 months after delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of anamnestic parameters | 12 months | For all enrolled patients a detailed medical history was collected, including following parameters: sex, region, brushing, mouth rinsing, flossing, alcohol consumption, stress, periodontitis therapy, gingival biotype. |
Countries
Germany
Outcome results
None listed