Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Bone Loss, Alveolar, Dental Implant Failed
About this trial
This is an interventional treatment trial for Bone Loss, Alveolar
Eligibility Criteria
Inclusion Criteria:
- able to sign an informed consent form
- aged 25 years or more
- Any patient requiring two implant-supported crowns in the lower or upper jaw
- Kennedy class I, II, and III;
- teeth extracted at least 6 months before implant placement;
- sufficient bone volumes to accommodate dental implants without augmentation procedure
Exclusion Criteria:
- General medical and/or psychiatric contraindications to implant surgery,
- Pregnancy or nursing,
- Heavy smoking (more than 10 cigarettes/day),
- Treatment with anticoagulant drugs (International Normalized Ratio under 1.8), bisphosphonates, steroid therapy or anticonvulsants drugs.
- No regenerated bone
- Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
- Patients with history of alcohol, narcotics or drug abuse. (Alcoholism: more than two bottles of beer per day)
- Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment, or who have been administered radiotherapy in the last 5 years. (Patients through at any time received radiotherapy to the head and neck region should be excluded anyway.)
- Metabolic bone disorders
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
- Degenerative diseases.
- Osteoradionecrosis.
- Renal failure.
- Organ transplant recipients.
- HIV positive.
- Malignant diseases.
- Diseases that compromise the immune system.
- Unbalanced diabetes mellitus. (HbA1c above 6.5), Uncontrolled endocrine diseases
- Psychotic diseases.
- Hypersensitivity to one of the components of the implant in general and titanium in particular.
- Women who are pregnant or lactating.
- Lack of patient cooperation.
- Parafunctional habits, such as Bruxism or Temporomandibular joint disease.
- Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus, malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
Sites / Locations
- Clínica Odontológica de la Universitat de Valencia, Fundación Lluis AlcanyisRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Internal hexagon connection
Conical connection
Small flaps will be elevated to reduce any kind of injury on the periosteum and maintain the blood supply during the healing period. Patients will receive 2 implants. One implant (assigned randomly) will have internal hexagon connection. The Internal Hex (IH) implant has a 2.5mm internal hexagon and a 90° cone. The platform diameter is Ø3.5mm.
Small flaps will be elevated to reduce any kind of injury on the periosteum and maintain the blood supply during the healing period. Patients will receive 2 implants. One implant (assigned randomly) will have internal hexagon connection. The Conical Standard (CS) implant has a 2.5mm internal hexagon and 22° cone. The platform diameter is Ø3.1mm.