Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement
- Conditions
- Tooth Avulsion
- Interventions
- Procedure: Tooth extractionProcedure: Tooth extraction and Alveolar ridge preservation
- Registration Number
- NCT04299750
- Lead Sponsor
- Simone Lumetti
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
-
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;
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Natural healing Tooth extraction Patients in this arm will undergo atraumatic extraction of an hopeless tooth. The socket will follow natural healing. Alveolar Ridge Preservation Tooth extraction and Alveolar ridge preservation Patients in this arm will undergo atraumatic extraction of an hopeless tooth and a socket preservation procedure. Alveolar ridge preservation will be performed using a slow-resorption bone substitute and a collagen membrane that covers the graft.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Centro Universitario di Odontoiatria
🇮🇹Parma, PR, Italy