Clinical trial NCT06627023: 3D Analysis of Peri-implant Soft Tissue with Two Different Connection Types
Official title: 3D Analysis of PERI-IMPLANT SOFT TISSUE After Dental Implant Placement with CONICAL and BUTT-JOINT Connection: a 12-Month Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Keywords: Dental Implants, Implant-Abutment Connection Types, Conical Connection, Butt-Joint Connection, Peri-Implant Soft Tissue, Digital Monitoring
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 38
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Linear changes of soft tissue in mm
timeFrame: 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.
Secondary outcomes:
measure: Influence of anamnestic parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References:
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