Bone Material's Histomorphometric Analysis In Socket Preservation
Not Applicable
Not yet recruiting
- Conditions
- Socket Preservation
- Registration Number
- NCT06740110
- Lead Sponsor
- Medical Inventi S.A.
- Brief Summary
This prospective, multicentre, split-mouth randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Patients over 18 years old with full legal capacity, male and female;
- Patients with ability to understand the proposed surgical treatment and to understand and sign the informed consent;
- Patients who are willing and able to comply with scheduled visits, treatment and other trial procedures;
- Patients who respect the follow-up recalls.
Exclusion Criteria
- Presence of bone lesions;
- Patients with alcohol or substance abuse;
- Patients with smoking habits (more than 10 cigarettes per day);
- Patients presenting physical and/or mental handicap that impede an adequate oral hygiene;
- Pregnant or breast feeding women;
- Patients currently participating in any other clinical investigation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure. 6 months A new bone formation assesses via histomorphometric evaluation.
- Secondary Outcome Measures
Name Time Method Evaluation of (serious) adverse events (S)AEs. 13 months Number of (S)AEs
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular pathways (e.g., RANKL, BMP) drive bone regeneration in socket preservation using NCT06740110's investigational graft?
How does histomorphometric bone formation with NCT06740110's graft compare to xenograft/allograft standards in socket preservation?
Which biomarkers (e.g., osteocalcin, TRAP5b) predict successful bone regeneration outcomes in socket preservation trials?
What adverse events (e.g., graft resorption, infection) are associated with socket preservation materials in NCT06740110?
How do combination therapies (e.g., PRP, PBM) enhance socket preservation outcomes compared to standalone bone grafts?