Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments

NCT ID: NCT06455436

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2026-07-15

Brief Summary

The loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of the tissues. This technique can be performed with standard abutments after implant placement or, more recently, the use of temporary abutments has been proposed.

Detailed Description

Objective: To check if custom healing abutments manufactured using CAD/CAM technique in immediate implants promote greater dimensional stability of the peri-implant tissue compared to standard healing abutments.

Methods: After the extraction, an immediate Klockner Vega+ implant will be placed and the gap will be filled with a bone substitute (Cerabone, Botiss). The patient will then be randomized to the control group (standard healing abutment) or the test group (custom healing abutment using CAD/CAM technique). In the latter case, a peripheral seal is achieved, allowing for wound closure and stabilization of the clot with the same shape as the crown in its transmucosal part.

Conditions

Dental Implant; Immediate Dental Implant; Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Will receive standard healing abutments

Group Type: ACTIVE_COMPARATOR

Standard healing abutment

Intervention Type: DEVICE

Participants will undergo a surgery to place an immediate klockner dental implant and will be receive a standard healing abutment

Individualized healing abutment group

Will receive individualized healing abutments

Group Type: EXPERIMENTAL

Individualized healing abutment

Intervention Type: DEVICE

Participants will undergo a surgery to place an immediate klockner dental implant and will be receive an individualized healing abutment

Interventions

Standard healing abutment

Participants will undergo a surgery to place an immediate klockner dental implant and will be receive a standard healing abutment

Intervention Type: DEVICE

Individualized healing abutment

Participants will undergo a surgery to place an immediate klockner dental implant and will be receive an individualized healing abutment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patient ( 25 years old).
• Need for extraction of an irrational tooth to be treated in the molar/premolar position of the upper/lower arch.
• Presence of 2mm of keratinized gingiva.
• Bone dehiscence in the alveolar walls of 2 mm. 2 mm.
• Adequate amount of bone in the interradicular septum to stabilize the implant (minimum height 10 mm, minimum width 4 mm at the base of the septum).
• Plaque index (FMSPI, full mouth score plaque index) < 10%.
• Non-smokers or smokers of less than 10 cigarettes per day.
• Absence of systemic diseases that contraindicate implant surgery.

Exclusion Criteria

• Presence of alveoli with dehiscence >2mm.
• Presence of adjacent implants.
• < 2mm of keratinized gingiva.
• Presence of active infection (fistula, suppuration) at the extraction site.
• Presence of apical granuloma >2mm in diameter in the root(s) of the tooth or teeth to be extracted.
• Residual bone apical to the extraction insufficient to anchor the implant.
• Pregnant or lactating women.
• Severe cognitive or psychiatric disorders.
• Compromised general health status ( ASA IV).
• Use of drugs that alter bone metabolism and healing.
• Absence of manual primary stability of the implant
• Bone dehiscence or fenestration after implant placement (manual rotation).
• Gap 2mm between the implant and the vestibular bone wall.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matteo Albertini, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Internacional de Catalunya

Locations

Universitat Internacional de Catalunya

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Javi Vilarrasa, MSc

Role: CONTACT

jvilarrasa@uic.es

+34 628553000

Nicolas Padros, DDs

Role: CONTACT

nico.padros@uic.es

+34 628289185

Facility Contacts

Javi Vilarrasa, Mr

Role: primary

jvilarrasa@uic.es

Other Identifiers

PER-ECL-2023-10

Identifier Type: -

Identifier Source: org_study_id