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Completed

NCT Number: NCT05360693

Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

For the dimension of the peri-implant buccal gap, a controversy is present whether complete bone formation labial to the implant. Therefore, leaving the blood clot in the large socket around implants without augmentation is questionable to result in complete bone fill and would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate the labial bone dimensional changes after immediate implant placement in the esthetic zone with & without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.

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Key information

Conditions

Immediate Implants Esthetic Zone Labial Bone Dimensional Changes Thin Labial Plate of Bone Pre-extraction With Labial Grafting Without Labial Bone Grafting

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Dental Continuing Education, Cairo, Maadi, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult (>20 years) with non-restorable maxillary teeth in the esthetic zone,
  • thick gingival phenotype,
  • intact but thin labial plate of bone (≤1mm)
  • intact palatal bone extending at least 6mm apically,
  • sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)
  • labio-palatal socket dimension measured from the CBCT axial cut at mid-crestal part ≥5mm.
  • patients agreed to sign a written informed consent.

Exclusion criteria

  • smokers,
  • pregnant women,
  • patients with systemic disease,
  • patients with parafunctional habits such as bruxism or clenching,
  • infected socket,
  • periapical pathosis
  • history of radiotherapy or chemotherapy within the past 2 years.

Treatment and study plan

immediate implant placement without bone grafting

Procedure

After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done & patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.

immediate implant placement with socket bone grafting

Procedure

After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done and patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). In order to ensure standardization and reproducibility of the CBCT cross sectional images used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.

Primary outcomes

  1. Amount of bone labial to the implant

    Time frame: 1 year

    CBCT superimposition (fusion scans)

  2. Horizontal labio-palatal bone width

    Time frame: 1 year

    CBCT superimposition (fusion scans)

  3. horizontal labio-palatal bone collapse

    Time frame: 1 year

    CBCT superimposition (fusion scans)

  4. vertical bone dimensional changes

    Time frame: 1 year

    CBCT superimposition (fusion scans)

Secondary outcomes

  1. gingival index

    Time frame: 1 year

    bleeding on probing around customized healing abutments placed on the immediate implants

  2. Implant failure

    Time frame: 1 year

    The following are the criteria of the implant success: the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ≧ 5 mm, and without vertical bone loss ≧ 1.5 mm in the first year. The cases will be defined as failure if it can't reach any one of the success criteria.

  3. Plaque Index

    Time frame: 1 year

    Plaque index

  4. Postoperative Pain

    Time frame: 1 day, 3 days, 7 days

    VAS

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Horizontal and Vertical Labial Bone Dimensional Changes After Flapless Immediate Implant Placement With and Without Bone Grafting: A 1-year Cone-beam Computed Tomography Randomized Clinical Trial.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 4, 2022
Registry last updated
Sep 8, 2022

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

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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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