Immediate Implant Placement in the Posterior Region Combining Sealing Socket Abutment and Peri-implant Socket Filling.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Liege

About this trial

The primary endpoint of this study is to compare the soft tissue contour changes after immediate implant placement combined to peri-implant socket filling with a sealing socket abutment (SSA) versus a standard healing abutment. The hypothesis is that the SSA better preserves the alveolar ridge profile in the cervical region compared to a conventional healing abutment. The secondary objectives aim to evaluate 3D hard tissue changes, peri-implant bone remodeling, soft tissue health, esthetic outcomes and the patients related outcome measures.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Good general health (ASA I/II),

More than 18 years old,

Smoker < 10c/day, one hopeless tooth,

Healthy periodontal condition,

Disqualifiers

Auto-immune disease or immunocompromised patients

Uncontrolled diabetes

Use of steroids or biphosphonates

Local or systemic infection (medical treatment needed prior to entrance to the study)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Socket Seal Abutment

    Device

    Customized Healing Abutment

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Socket Seal AbutmentExperimental treatment 1 intervention
Group B: Conventional Healing abutmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of Soft Tissue Contour from baseline to 3 months, 6 months and 1 year

Compare the soft tissue contour changes after immediate implant placement combined to peri-implant socket filling with a sealing socket abutment (SSA) versus a standard healing abutment.

Time frame
3 months, 6 months, 1 year

Secondary outcomes

1

3D hard tissue changes

Assessment of bone dimension changes

Time frame
Baseline, 1 year
2

Peri-implant bone remodeling

Assessment of bone height changes

Time frame
3 months, 6 months, 1 year
3

Soft tissue health changes assessed by Probing Pocket Depth

Assessed of probing depth

Time frame
3 months, 6 months, 1 year
4

Soft tissue health changes assessed by Bleeding on Probing

Assessment of the bleeding percentage

Time frame
3 months, 6 months, 1 year

Other outcomes

Sponsors and contacts

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