Actively Recruiting
Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.
Led by Universitat Internacional de Catalunya · Updated on 2024-12-11
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing changes in soft tissue volume and patient-reported outcomes around dental implants using three different graft materials: a sub-epithelial connective tissue graft (SCTG) from the palate, porcine collagen matrix (CM), and porcine acellular dermal matrix (PADM). This phase 4 randomized clinical trial aims to evaluate volume gain and stability at 3 and 15 months after implant placement. The study involves four groups: one receiving implant placement and prosthetic tooth rehabilitation alone, and three groups receiving implant placement plus soft tissue augmentation with either SCTG, CM, or PADM at the implant site, followed by prosthetic rehabilitation. SCTG grafts are harvested from the palate and trimmed to specific dimensions, while CM and PADM grafts are similarly trimmed and secured at the recipient site. Implant placement includes making a crestal incision and preparing the bone to place a tapered implant with a healing abutment. Participants will undergo assessments including soft tissue volume gain at 3 months and volume stability at 15 months. Additional measures include plaque index, bleeding on probing, probing depth, keratinized tissue width, phenotype evaluation at baseline, 12 weeks, and 15 months, as well as patient-reported outcomes shortly after surgery. Pink Esthetic Score will be evaluated around 16 months after crown placement. Safety and progress will be monitored throughout the study with a total participation period extending beyond 15 months.
CONDITIONS
Brief Title
Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients in need of a single implant with soft tissue augmentation due to buccal defects, thin biotype, lack of keratinized tissue, or aesthetic concerns.
- Age 18 years or older and able to understand the surgery and provide informed consent.
- Implant located between two fixed reference points (clinical crowns).
- Implant site between anterior and premolar teeth (from premolar to premolar).
- Sufficient crestal bone width to maintain at least 2mm thickness at the buccal bone plate.
- Palate thickness of at least 2mm in the premolar area.
- Full mouth plaque and bleeding scores less than 20%.
You will not qualify if you...
- Pregnant or breastfeeding individuals.
- Active periodontal disease.
- Previous soft tissue augmentation in the implant area.
- Need for guided bone regeneration during or after implant placement.
- Heavy smokers (more than 10 cigarettes per day).
- Local or systemic conditions interfering with periodontal therapy, including uncontrolled diabetes, cancer, HIV, high-dose steroid therapy, bone metabolic diseases, radiation exposure, immunosuppressive disorders, liver disorders, autoimmune diseases.
- Allergy to non-steroidal anti-inflammatory drugs.
- Use of medications that cause gum enlargement.
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 - Approximately 3 months
Participants receive implant placement, with or without soft tissue graft augmentation using one of three different graft materials, followed by prosthetic rehabilitation of the missing tooth.
1 surgical visit and follow-up visits for suture removal and assessment within the first week
Duration - Up to 15 months
Participants undergo assessments of soft tissue volume gain, stability, and other clinical parameters over time after the treatment.
Visits at baseline, 12 weeks, 7 days post-surgery (suture removal), and at 15 months, including evaluation after crown placement around 16 months
Trial Site Locations
Total: 1 location
1
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
Actively Recruiting
Research Team
A
Andres Pascual La Rocca, DDS
C
Cristina Valles Vega, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here