Health TrialsbyHealthPanel

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

ConditionsDental ImplantImmediate Dental ImplantWound Heal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversitat Internacional de Catalunya

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of alveoli with dehiscence >2mm.

Presence of adjacent implants.

< 2mm of keratinized gingiva.

Presence of active infection (fistula, suppuration) at the extraction site.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard healing abutment

    Device

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

  • Individualized healing abutment

    Device

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Individualized healing abutment groupExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
12 months

Secondary outcomes

1

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

Dehiscence can be assessed by carefully examining the peri- implant mucosa for any signs of tissue separation or exposure. This can be done visually during clinical examination.

Time frame
12 months
2

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

To measure dimensional changes in the alveolar bone, you can use cone-beam computed tomography (CBCT) scans. Compare CBCT images taken at different time points to quantify any changes in bone dimensions. measure dimensional changes in the alveolar bone, you can use cone-beam computed tomography (CBCT) scans. Compare CBCT images taken at different time points to quantify any changes in bone dimensions.

Time frame
12 months
3

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

CBCT scans can also be used to assess horizontal remodeling of the cortical bone. Analyze the CBCT images to measure changes in cortical thickness or contour.

Time frame
12 months
4

Thickness of vestibular and lingual/palatal cortex (CBCT)

CBCT scans can provide measurements of cortical thickness in the vestibular and lingual/palatal regions of the alveolar bone.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitat Internacional de Catalunya

Lead sponsor

Source ClinicalTrials.gov
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