Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Loss, Alveolar
- Sponsor
- University of Valencia
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Peri-implant bone level changes
- Last Updated
- 7 years ago
Overview
Brief Summary
This study designed as a randomized controlled split-mouth trial will be conducted at the Dental Clinic of the University of Valencia. The aim will be to assess differences in clinical, radiological and microbiological outcomes between implants with 2 different connections: internal hexagon and conical connection. Following the premises, to minimize the bias related to prosthetic phase and maximize the effect of connections on MBL changes, a 1abutment-1time protocol will be used.
The study hypothesis is that there will be no statistically significant differences between both implant connections.
Investigators
David Peñarrocha Oltra
Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)
University of Valencia
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.
Outcomes
Primary Outcomes
Peri-implant bone level changes
Time Frame: a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).
calculated using intraoral digital periapical radiographs
Secondary Outcomes
- Prosthetic complications(3 years)
- Plaque(a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).)
- Resonance frequency analysis values(a. implant placement (baseline) b. abutment connection (8-12 weeks))
- Probing pocket depth(a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).)
- Implant failure(3 years)
- Microbial loads(12 months after loading)
- Bleeding on probing(a. implant placement (baseline), b. abutment connection (8-12 weeks), c. after 1 year of function (14-15 months), d. after 3 years of function (38-39 months).)