Clinical trial NCT06455436: Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments
Official title: Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments Using a CAD/CAM Technique: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Immediate Dental Implant
Wound Heal
Keywords: implant
soft tissue
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Buccal-lingual/palatal soft tissue dimensional changes
timeFrame: 12 months
Secondary outcomes:
measure: Dehiscence of peri-implant vestibular and lingual/palatal mucosa:
timeFrame: 12 months
measure: Vestibulo-lingual/palatal dimensional changes of the alveolar bone (CBCT)
timeFrame: 12 months
measure: Horizontal remodeling of vestibular and lingual/palatal cortex (CBCT)
timeFrame: 12 months
measure: Thickness of vestibular and lingual/palatal cortex (CBCT)
timeFrame: 12 months
measure: Vertical changes of the vestibular and lingual/palatine cortex (CBCT)
timeFrame: 12 months
measure: Marginal bone level (periapical x-ray)
timeFrame: 12 months
measure: Probing pocket depth
timeFrame: 12 months
measure: Bleeding/Suppuration on probing
timeFrame: 12 months
measure: Implant survival
timeFrame: 12 months
measure: Patient-reported variables (satisfaction, pain)
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya
state: Catalonia
Study officials:
affiliation: Universidad Internacional de Catalunya
name: Matteo Albertini, PhD
role: PRINCIPAL_INVESTIGATOR
References: