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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implantation
• Intervention / Treatment: Device: Socket Seal Abutment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno De Carvalho, DDS, Ms, PhD Fellow; Phone Number: +32479510961; Email: bruno.decarvalho@chuliege.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liège
    • Contact: Bruno De Carvalho, DDS, MS; Email: bruno.decarvalho@chuliege.be
    • Principal Investigator: Bruno De Carvalho, DDS, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Socket Seal Abutment	Device: Socket Seal Abutment; Customized Healing Abutment
Active Comparator: Conventional Healing abutment	Device: Socket Seal Abutment; Customized Healing Abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D hard tissue changes	Assessment of bone dimension changes	Baseline, 1 year
Peri-implant bone remodeling	Assessment of bone height changes	3 months, 6 months, 1 year
Soft tissue health changes assessed by Probing Pocket Depth	Assessed of probing depth	3 months, 6 months, 1 year
Soft tissue health changes assessed by Bleeding on Probing	Assessment of the bleeding percentage	3 months, 6 months, 1 year
Soft tissue health changes assessed by Plaque Index	Assessment of plaque percentage	3 months, 6 months, 1 year
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	10 days, 3 months, 6 months, 12 months
Patients Related Outcome Measures	Assessed by questionnaire	6 months, 1 year

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): October 1, 2025
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Estimate): February 23, 2023

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Immediate implant; Sealing Socket Abutment; Peri implant tissue changes
• Other Study ID Numbers: 2022/19 (Other Identifier: Bezmialem Vakif University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No