Teeth with poor prognosis scheduled for extraction Oral Health
Conditions
Interventions
This is a randomized, parallel-arm clinical study designed to evaluate the efficacy of two alveolar ridge preservation (ARP) techniques following tooth extraction. Forty participants requiring extract
Sponsors
ARDEC Academy
Eligibility
Sex/Gender
All
Age
21 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 21 years or older 2. Presence of at least one tooth with poor prognosis (e.g., due to advanced periodontal disease, vertical root fracture, endodontic failure, or non-restorable caries) requiring extraction 3. Extraction sites limited to premolars, canines, or maxillary incisors 4. Adequate oral hygiene and willingness to maintain it throughout the study period 5. Sufficient bone volume and soft tissue condition to allow flap elevation and alveolar ridge preservation procedures 6. Good general systemic health, with no contraindications for routine oral surgery 7. Non-pregnant and non-lactating women 8. Ability and willingness to understand the study procedures, sign informed consent, and comply with all study visits and follow-up appointments
Exclusion criteria
Exclusion criteria: 1. Presence of any uncontrolled systemic disease (e.g., diabetes mellitus, cardiovascular disorders, coagulation defects, immune suppression) 2. History of radiotherapy or chemotherapy to the head or neck region 3. Current or recent use (within the past 6 months) of medications known to affect bone metabolism, such as bisphosphonates, denosumab, or long-term corticosteroids 4. Smokers of more than 10 cigarettes per day or users of other tobacco products 5. History of previous bone regeneration procedures or implant placement at the intended surgical site 6. Presence of acute infection, abscess, fistula, or cystic lesion at the tooth to be extracted 7. Severe periodontal disease extending beyond the target tooth and compromising adjacent bone 8. Allergy or hypersensitivity to any of the study materials (xenograft, collagen membrane, or lamina) 9. Pregnant or breastfeeding women 10. Patients who are unable or unwilling to attend scheduled follow-ups or provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Linear and volumetric changes of the alveolar ridge measured using cone-beam computed tomography (CBCT) and 3D analysis of digital impressions at baseline (pre-extraction) and 6 months after alveolar ridge preservation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of newly formed bone measured using histomorphometric analysis of resin-embedded biopsy sections obtained with trephine burs at 6 months after alveolar ridge preservation (during implant site preparation) 2. Percentage of residual graft material measured using histomorphometric analysis of resin-embedded biopsy sections at 6 months after alveolar ridge preservation 3. Presence of inflammatory cells and vascularization assessed through light microscopy of stained histological sections at 6 months after alveolar ridge preservation 4. Soft tissue healing quality evaluated through clinical examination and photographic documentation at 2 weeks (suture removal) and 6 months | — |
Countries
Cuba
Contacts
Public ContactDaniele Botticelli
Outcome results
None listed