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

NCT06455436 | Recruiting

• 1 other identifier: PER-ECL-2023-10
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Immediate Dental Implant; Wound Heal

Keywords

implant; soft tissue

Outcome Measures

Primary Outcomes (1)

• Buccal-lingual/palatal soft tissue dimensional changes

  They will be evaluated after superimposing the initial STL files with the follow-up ones. In addition, photos, periapical radiographs and a new intraoral scan at 3 months, 6 months and 1 year will be taken. In a 2D buccal-lingual slice corresponding to the center of the ridge, measure at the vestibular and palatal level from the point of maximum preoperative STL soft tissue contour (mucosal margin and at 3 mm and 5 mm apical to the margin).

  12 months

Secondary Outcomes (10)

• Dehiscence of peri-implant vestibular and lingual/palatal mucosa:

  12 months

• Vestibulo-lingual/palatal dimensional changes of the alveolar bone (CBCT)

  12 months

• Horizontal remodeling of vestibular and lingual/palatal cortex (CBCT)

  12 months

• Thickness of vestibular and lingual/palatal cortex (CBCT)

  12 months

• Vertical changes of the vestibular and lingual/palatine cortex (CBCT)

  12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Will receive standard healing abutments

Device: Standard healing abutment

Individualized healing abutment group

EXPERIMENTAL

Will receive individualized healing abutments

Device: Individualized healing abutment

Interventions

Standard healing abutment DEVICE

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

Control group

Individualized healing abutment DEVICE

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

Individualized healing abutment group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, Catalonia, 08195, Spain

RECRUITING

Study Officials

• Matteo Albertini, PhD

  Universidad Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javi Vilarrasa, MSc

CONTACT

+34 628553000; jvilarrasa@uic.es

Nicolas Padros, DDs

CONTACT

+34 628289185; nico.padros@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 12, 2024
• Study Start: May 8, 2024
• Primary Completion: July 15, 2025
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 12, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)