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Immediate ImplantsNCT05360693

Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

A study testing immediate implant placement without bone grafting and immediate implant placement with socket bone grafting in people with Immediate Implants and Esthetic Zone, run by Cairo University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
What is being tested?
immediate implant placement without bone grafting and immediate implant placement with socket bone grafting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesEgypt
Study dates
1 Nov 2020to 29 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • International Dental Continuing Education

    Cairo, Maadi, 11728

  • Faculty of Dentistry, Cairo University

    Cairo, Manial, 35855

Other trials in Egypt

About this study

Official 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.

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.

Being tested
immediate implant placement without bone grafting, immediate implant placement with socket bone grafting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • immediate implant placement without bone graftingProcedure or surgery

    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 graftingProcedure or surgery

    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.

Study groups in NCT05360693
Study groupRoleWhat they receive
immediate implant placement without bone graftingExperimentalAfter atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. Patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface.
Receives: Procedure: immediate implant placement without bone grafting
immediate implant placement with bone graftingActive comparatorAfter atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done 3-5mm into the bone apical to the socket according to the manufacturer's instructions. 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.
Receives: Procedure: immediate implant placement with socket bone grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of bone labial to the implant

    CBCT superimposition (fusion scans)

    Measured: 1 year

  2. Horizontal labio-palatal bone width

    CBCT superimposition (fusion scans)

    Measured: 1 year

  3. horizontal labio-palatal bone collapse

    CBCT superimposition (fusion scans)

    Measured: 1 year

  4. vertical bone dimensional changes

    CBCT superimposition (fusion scans)

    Measured: 1 year

Secondary outcomes (4)

  1. gingival index

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

    Measured: 1 year

  2. Implant failure

    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.

    Measured: 1 year

  3. Plaque Index

    Plaque index

    Measured: 1 year

  4. Postoperative Pain

    VAS

    Measured: 1 day, 3 days, 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start1 Nov 2020
  3. Primary completion1 Apr 2022
  4. Study completion29 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05360693
Sponsor's protocol ID
IDCE.N1
Status last verified
Sep 2022
First submitted
30 Apr 2022
Last updated
8 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing immediate implant placement without bone grafting and immediate implant placement with socket bone grafting in people with Immediate Implants and Esthetic Zone, run by Cairo University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of bone labial to the implant (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05360693.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.

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