Peri-implant Bone Level, Peri-implant Bone Loss, Peri-implant Marginal Bone Loss, Transmucosal Abutment Design
Conditions
Keywords
periimplant bone loss, abutment design, transmucosal abutment
Brief summary
The objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height
Detailed description
Patients will receive from one to eight bone-level implants according to their rehabilitation necessity and transmucosal abutments will be connected the day of the surgery. The control group will receive conventional transmucosal abutments while the test group will receive TCP abutments, with a narrower design. Results will be evaluated initially 6 and 12 months after the connection of the definitive prostheses, and finally 3 years later.
Interventions
DEVICEConventional transmucosal abutment design
The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one
DEVICENarrow transmucosal abutment design
The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one
Sponsors
Mozo Grau Ticare Implants
University of Santiago de Compostela
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
None of the participants or the outcomes assessor will know the device (transmucosal abutment) received. The care provider will connect the transmucosal abutment while the surgery, after opening the randomization envelope; and the investigator will identify the participant's group while analysing the radiographs.
Intervention model description
For each participant on the test group will be another participant on the control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Absence of systemic and periodontal pathology, over 18 years of age, with a plaque index below 25%. * Absence of at least one tooth, with natural adjacent teeth, allowing a prosthetic rehabilitation with an osseointegrated implant and a prosthetic unit. * Adequate bone quality available, allowing placement of MOZO GRAU® implants InHex STD QUATTRO with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm. * Natural teeth or implants with fixed restoration as antagonists.
Exclusion criteria
* Systemic factors: * Continuous administration of systemic medication that can interfere with the bone metabolism or medical conditions requiring prolonged use of steroids and / or medications that can interfere with bone metabolism. * History of leukocyte dysfunction and deficiency, immunodeficiency syndromes, kidney failure or bone metabolic disorders, such as osteoporosis. * Physical disability that may interfere with proper oral hygiene. * Use of any investigational medication or device within the previous 30 days to implant surgery in the study. * Alcoholism or drug addiction * Smoker of more than 10 cigarettes per day. * Conditions or circumstances that could prevent compliance with participation in study or interfere with the analysis of results, such as a history of breach or unreliability. Local factors: * History of local radiotherapy. * Bruxism. * Diseases that affect the oral mucosa, such as oral lichen planus. * Untreated periodontitis. * Persistent intraoral infection. * Post-extraction alveoli not cured (less than 6 weeks after extraction).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic marginal periimplant bone level changes | from baseline (connection of the definitive abutment) to 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | Measured as the distance from the bone crest to the first implant-to-bone contact. This will be assessed on parallelized periapical radiographies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Papilla refill | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | Evaluated according to the Jemt 1997 index |
| Bleeding on probing | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | Evaluated according to the Mombelli 1987 index, presence of bleeding after probing |
| Probing pocket depth | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | measured with a CP12 probe as the distance from the soft tissue margin to the bottom of the peri-implant pocket |
| Patient Reported Outcomes Measurements | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | Using a visual analoge scale from 1 to 10 to evaluate patient's satisfaction parameters related to the aesthetics, masticatory ability, confort, general satisfaction and phonetics |
| Adverse effects frequency | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | Presence of adverse effects during the follow-up, such as fracture of the implant or the prosthetic unit or presence of periimplantitis or mucositis |
| Plaque index | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | Evaluated according to the Mombelli 1987 index, presence of plaque |
Countries
Spain
Contacts
Primary ContactLucia Maceiras
Outcome results
None listed