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Dental ImplantationRCTNCT05741749

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

A study testing Socket Seal Abutment in people with Dental Implantation, run by University of Liege at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Dental Implantation
What is being tested?
Socket Seal Abutment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBelgium
Study dates
1 Oct 2022to 1 Oct 2026
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 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Good general health (ASA I/II),
  • More than 18 years old,
  • Smoker < 10c/day, one hopeless tooth,
  • Healthy periodontal condition,
  • Presence of at least 2 mm of keratinized gingiva
  • Intact buccal bone wall
Show all 9Show fewer
  • Adequate plaque control (FMPS ≤ 25%)
  • Adequate bone quantity allowing an immediate implant procedure (apical bone height of at - Least 5 mm or presence of interradicular septum)
  • Written consent provided

Who cannot join

  • 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)
  • Pregnancy or breastfeeding
  • Alcoholism or chronically drug abuse
Show all 12Show fewer
  • Bone availability requiring an angulated abutment
  • Untreated local inflammation
  • Cyst
  • Mucosal disease or oral lesions
  • Local irradiation therapy
  • Oral communication with sinus after the extraction

Trial locations and contacts

1 site in 1 country.

Bruno De Carvalho, DDS, Ms, PhD Fellow contact

+32479510961

bruno.decarvalho@chuliege.be

Belgium1 site, 1 recruiting
  • CHU de Liège

    Liège, 4000

    Bruno De Carvalho, DDS, MS, bruno.decarvalho@chuliege.be

    Bruno De Carvalho, DDS, MS

    Recruiting

Other trials in Belgium

About this study

Official title: Immediate Implant Placement in the Posterior Region Combining Sealing Socket Abutment and Peri-implant Socket Filling.A Randomized Controlled Clinical 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.

Read the detailed description

Study population

Hopeless maxillary or mandibular molars with tooth anatomy and bone anchorage allowing an immediate implant procedure: apical bone height of at least 5 mm or presence of interradicular septum, socket with intact bone walls, absence a large apical periodontitis, Patients needing tooth replacement in the posterior region (molars) will be recruited from the Department of Periodontology and Oral and Implant Surgery of the University of Liège, Belgium. All the patients will meet the following inclusion criteria: good general health (ASA I/II), more than 18 years old, smoker < 10c/day, one hopeless tooth, healthy periodontal condition, the presence of at least 2 mm of keratinized gingiva, intact buccal bone wall, adequate plaque control (FMPS ≤ 25%), adequate bone quantity allowing an immediate implant procedure (apical bone height of at least 5 mm or presence of interradicular septum) and finally written consent provided. The exclusion criteria will be: 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), pregnancy or breastfeeding, alcoholism or chronically drug abuse. The local exclusion criteria will be: bone availability requiring an angulated abutment, untreated local inflammation, cyst, mucosal disease or oral lesions, local irradiation therapy, oral communication with sinus after the extraction. All the patients will have to read and sign the informed consent form prior to the surgery.

Procedures

After a local anesthesia, in both groups, experienced surgeons will proceed to minimally invasive tooth extraction of the hopeless tooth. The consecutive drills for implant placement will be carried out according to the recommendation of the manufacturer while considering the future position of the crown for a screw-retained restoration and the socket anatomy. Then, implants (TLX, SLA active, Straumann Group, Basel, Switzerland) will be placed immediately in a flapless manner and an insertion torque of at least 20Ncm will be required to continue the procedure. The remaining socket will be filled with a Deproteinized Bovine Bone Mineral DBBM (Straumann Xenograft, Straumann Group, Basel, Switzerland). Once the implant placed and the socket procedure completed the patients will be allocated either to the control group or the test group. In control group, a conventional healing abutment will be placed and the remaining gap of the socket will be closed with collagen matrix (Collacone, Straumann Group, Basel, Switzerland). In the test group, an SSA will be made immediately in a chair-side manner. A Variobase (Straumann Group, Basel, Switzerland) will be placed at the implant and Teflon will be used to protect the biomaterial and implant neck. Flowable composite will be used to start shaping the form of the future SSA. On the chair-side, the finalization of the emergence profile in a tulip concave shape by additive technique will take place. Before insertion, the SSA will be polished, cleaned and disinfected in a series of ultrasonic baths (Soapy water, water and alcohol). The insertion will be made at 15 N/cm and the access hole will be obturated with teflon and Telio (Ivoclar vivadent, Schaan, Liechtenstein). A standardized parallel peri-apical radiograph using a custom-made film holder will be taken in order to record the baseline bone level. Each patient will be instructed to rinse twice daily with an aqueous solution of 0,2% Chlorhexidine (Corsodyl®, GSK, Brentford, United Kingdom) and to avoid brushing of the area until the first recall 10-12 days later. Antibiotic will be prescribed (Amoxicillin® 500mg 3x/d during 5 days) and anti-inflammatories (Ibuprofen® 600 mg) as well as additional analgesics (Paracetamol® 500 mg) will recommended according to the patient's needs. Three months after implantation, in both groups, the abutments will be removed, the osseointegration of the implants will be checked and a CAD-CAM Zirconia monolithic crown will be placed. The transmucosal design from the SSA will replicated on the final crown and in the control group the design of the crown will be determined according to the soft tissue profile.

Follow-up evaluations and data recording will be performed 7-10 days, 3 months, 6 months and 12 months after the surgery.

Being tested
Socket Seal Abutment
Keywords
Sealing Socket Abutment, Immediate implant, Peri implant tissue changes

What participants receive

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

  • Socket Seal AbutmentDevice

    Customized Healing Abutment

Study groups in NCT05741749
Study groupRoleWhat they receive
Socket Seal AbutmentExperimentalNot described
Receives: Device: Socket Seal Abutment
Conventional Healing abutmentActive comparatorNot described
Receives: Device: Socket Seal Abutment

What is being measured

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

  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.

    Measured: 3 months, 6 months, 1 year

Secondary outcomes (7)
  1. 3D hard tissue changes

    Assessment of bone dimension changes

    Measured: Baseline, 1 year

  2. Peri-implant bone remodeling

    Assessment of bone height changes

    Measured: 3 months, 6 months, 1 year

  3. Soft tissue health changes assessed by Probing Pocket Depth

    Assessed of probing depth

    Measured: 3 months, 6 months, 1 year

  4. Soft tissue health changes assessed by Bleeding on Probing

    Assessment of the bleeding percentage

    Measured: 3 months, 6 months, 1 year

  5. Soft tissue health changes assessed by Plaque Index

    Assessment of plaque percentage

    Measured: 3 months, 6 months, 1 year

  6. Esthetic outcomes changes

    Assessed by Pink Esthetic Score (Papilla presence, tissue contour, gingival level, alveolar process, colouring and texture) as well as intra-oral photographs

    Measured: 10 days, 3 months, 6 months, 12 months

  7. Patients Related Outcome Measures

    Assessed by questionnaire

    Measured: 6 months, 1 year

Timeline

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

  1. First posted23 Feb 2023
  2. Study start1 Oct 2022
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Oct 2026 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Clinical Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05741749
Sponsor's protocol ID
2022/19
Acronym
RCT
Status last verified
Feb 2023
First submitted
18 May 2022
Last updated
23 Feb 2023
Results posted
No
Data monitoring committee
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 Socket Seal Abutment in people with Dental Implantation, run by University of Liege at 1 site in Belgium.

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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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?

Results are not available in the source record.

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

Contact Bruno De Carvalho, DDS, Ms, PhD Fellow (+32479510961, bruno.decarvalho@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Soft Tissue Contour from baseline to 3 months, 6 months and 1 year (time frame: 3 months, 6 months, 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Feb 2023.

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