Actively Recruiting
Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments Using a CAD/CAM Technique: Randomized Controlled Clinical Trial
Led by Universitat Internacional de Catalunya · Updated on 2024-06-12
32
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the dimensional changes of tissue around immediate dental implants, comparing custom-made healing abutments made with CAD/CAM technology to standard healing abutments. The goal is to see if these personalized abutments help maintain the tissue shape better after tooth extraction and implant placement. This randomized controlled clinical trial is sponsored by the Universitat Internacional de Catalunya and focuses on patients needing tooth extraction in molar or premolar areas. After tooth extraction, participants receive an immediate Klockner Vega+ implant, with the gap filled using a bone substitute. They are randomly assigned to receive either a standard healing abutment or a custom healing abutment made by CAD/CAM, which aims to create a better seal and stabilize the wound to maintain tissue shape. The treatment lasts for 12 months, during which tissue and bone changes are monitored. Participants will be followed for one year with regular evaluations including measurements of soft tissue and bone changes using clinical exams, CBCT scans, and X-rays. Researchers will assess implant survival, tissue healing, bone remodeling, and patient satisfaction including pain. These assessments help determine how well the different abutments maintain tissue stability and support healing after implant placement.
CONDITIONS
Brief Title
Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient 25 years old or older
- Need for extraction of a molar or premolar tooth in the upper or lower jaw
- Presence of at least 2 mm of keratinized gingiva (firm gum tissue)
- Bone dehiscence in alveolar walls of 2 mm or less
- Adequate bone amount in the interradicular septum to stabilize the implant (minimum height 10 mm, minimum width 4 mm)
- Plaque index less than 10%
- Non-smoker or smoking fewer than 10 cigarettes per day
- No systemic diseases that contraindicate implant surgery
You will not qualify if you...
- Presence of alveoli with dehiscence greater than 2 mm
- Presence of adjacent dental implants
- Less than 2 mm of keratinized gingiva
- Active infection such as fistula or suppuration at extraction site
- Apical granuloma larger than 2 mm in diameter at root(s) of tooth to be extracted
- Insufficient residual bone apical to extraction to anchor implant
- Pregnant or breastfeeding women
- Severe cognitive or psychiatric disorders
- Compromised general health status (ASA IV)
- Use of drugs that affect bone metabolism and healing
- Lack of manual primary stability of the implant
- Bone dehiscence or fenestration after implant placement
- Gap of 2 mm or more between implant and vestibular bone wall
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus initial healing period
Participants undergo extraction of a molar or premolar tooth and immediate placement of a Klockner Vega+ dental implant with either a standard or individualized healing abutment.
1 surgery visit and initial post-operative visits
Duration - 12 months
Participants are monitored for dimensional changes of peri-implant tissue and healing progress over 12 months after implant placement.
Regular follow-up visits during 12 months
Trial Site Locations
Total: 1 location
1
Universitat Internacional de Catalunya
Barcelona, Catalonia, Spain, 08195
Actively Recruiting
Research Team
J
Javi Vilarrasa, MSc
N
Nicolas Padros, DDs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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