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NCT Number: NCT05741749

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

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Liège

Liège, 4000, Belgium

Location status: Recruiting

Location contact

Bruno De Carvalho, DDS, MS

CONTACT

[email protected]

Bruno De Carvalho, DDS, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Socket Seal Abutment

Device

Customized Healing Abutment

Primary outcomes

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

    Time frame: 3 months, 6 months, 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.

Secondary outcomes

  1. 3D hard tissue changes

    Time frame: Baseline, 1 year

    Assessment of bone dimension changes

  2. Peri-implant bone remodeling

    Time frame: 3 months, 6 months, 1 year

    Assessment of bone height changes

  3. Soft tissue health changes assessed by Probing Pocket Depth

    Time frame: 3 months, 6 months, 1 year

    Assessed of probing depth

  4. Soft tissue health changes assessed by Bleeding on Probing

    Time frame: 3 months, 6 months, 1 year

    Assessment of the bleeding percentage

  5. Soft tissue health changes assessed by Plaque Index

    Time frame: 3 months, 6 months, 1 year

    Assessment of plaque percentage

  6. Esthetic outcomes changes

    Time frame: 10 days, 3 months, 6 months, 12 months

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

  7. Patients Related Outcome Measures

    Time frame: 6 months, 1 year

    Assessed by questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Bruno De Carvalho, DDS, Ms, PhD Fellow

CONTACT

[email protected]

+32479510961

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 23, 2023
Registry last updated
Feb 23, 2023

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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