Tooth Avulsion
Conditions
Keywords
Socket preservation, Single implant, Tooth extraction
Brief summary
The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.
Detailed description
The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.
Interventions
PROCEDURETooth extraction and Alveolar ridge preservation
Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal
PROCEDURETooth extraction
Tooth extraction and socket natural healing
Sponsors
Dentsply Sirona Implants and Consumables
Geistlich Pharma AG
Simone Lumetti
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 18 years of age * at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession; * adequate oral hygiene, i.e. plaque index score ≤10%; * mesial-distal width of inter-dental space ≥7 mm;
Exclusion criteria
* American Society of Anesthesiologists (ASA) score ≥III * presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing * a history of radiotherapy to the head and neck region * presence of conditions requiring chronic use of antibiotics * medical conditions requiring prolonged use of steroids * history of leucocyte dysfunction * history of bleeding disorders * history of renal failure * patients with metabolic bone disorders * patients with uncontrolled endocrine disorders * disability affecting oral hygiene * alcohol or drug abuse * HIV infection * smoking \>10 cigarettes a day or cigar equivalents * conditions or circumstances that would prevent completion of study participation * mucosal diseases * presence of osseous lesions * severe bruxing or clenching habits * persistent intraoral infections * compromised alveolus (dehiscence, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of implants ideally placed | 6 months | The main goal is to determine if alveolar ridge preservation affects optimal implant positioning. This is defined as the implant position allowing to fulfill the ideal prosthetic design of the crown to be restored. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-implant bone variation | 6 months | Crestal bone levels (CBL): distances from the implant shoulder to the most coronal bone to implant contact measured on X-rays with a millimeter ruler to the nearest 0.5 mm. Two measurements will be taken for each implant: mesially and distally |
| Ridge volume at 6 months after tooth extraction | 6 months | The comparison of baseline and control cone.beam computed tomography and of clinical data in test and control groups will allow to determine volumetric effects on bone and soft tissues of socket preservation. |
Countries
Italy
Outcome results
None listed