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

NCT05741749 | Recruiting

• 1 other identifier: 2022/19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Implantation

Keywords

Sealing Socket Abutment; Immediate implant; Peri implant tissue changes

Outcome Measures

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.

  3 months, 6 months, 1 year

Secondary Outcomes (7)

• 3D hard tissue changes

  Baseline, 1 year

• Peri-implant bone remodeling

  3 months, 6 months, 1 year

• Soft tissue health changes assessed by Probing Pocket Depth

  3 months, 6 months, 1 year

• Soft tissue health changes assessed by Bleeding on Probing

  3 months, 6 months, 1 year

• Soft tissue health changes assessed by Plaque Index

  3 months, 6 months, 1 year

Study Arms (2)

Socket Seal Abutment

EXPERIMENTAL

Device: Socket Seal Abutment

Conventional Healing abutment

ACTIVE COMPARATOR

Device: Socket Seal Abutment

Interventions

Socket Seal Abutment DEVICE

Customized Healing Abutment

Conventional Healing abutment; Socket Seal Abutment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

RECRUITING

Central Study Contacts

Bruno De Carvalho, DDS, Ms, PhD Fellow

CONTACT

+32479510961; bruno.decarvalho@chuliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Periodontology, oro-dental and implant surgery, Principal Investigator, Clinical Professor

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: February 23, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)