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Completed

NCT Number: NCT06627023

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

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.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 14197, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant Placement with Conical or Butt-Joint Connection

Device

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.

Primary outcomes

  1. Linear changes of soft tissue in mm

    Time frame: 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 outcomes

  1. Influence of anamnestic parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

3D Analysis of PERI-IMPLANT SOFT TISSUE After Dental Implant Placement with CONICAL and BUTT-JOINT Connection: a 12-Month Randomized Control Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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