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3D Analysis of Peri-implant Soft Tissue with Two Different Connection Types

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Completed

Conditions

Tooth Loss

Treatments

Device: Implant Placement with Conical or Butt-Joint Connection

Study type

Interventional

Funder types

Other

Identifiers

NCT06627023
EA4_111_24

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 2 patient groups

19 Patients Received Implants with Conical Connections
Active Comparator group
Description:
Thirty eight patients were enrolled and randomly assigned to receive implants with conical connection. For the first arm 19 patients received implants with conical connections. A standard healing abutment was placed after 6 months for two weeks. The definitive screw-retained crowns were manufactured digitally and delivered afterwards. The soft tissue changes were traced till 12 months post-op
Treatment:
Device: Implant Placement with Conical or Butt-Joint Connection
19 Patients Received Implants with Butt-Joint Connections
Active Comparator group
Description:
Thirty eight patients were enrolled and randomly assigned to receive implants with butt-joint connection. For the first arm 19 patients received implants with conical connections. A standard healing abutment was placed after 6 months for two weeks. The definitive screw-retained crowns were manufactured digitally and delivered afterwards. The soft tissue changes were traced till 12 months post-op
Treatment:
Device: Implant Placement with Conical or Butt-Joint Connection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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