The aim of this study will be to evaluate the non-inferiority of implants produced by additive manufacture loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up
This randomized Split-mouth clinical study of non-inferiority will monitor for one year partially edentulous patients in the posterior region of the mandible or maxilla, rehabilitated with 2 implants (AM) in the same Arch to evaluate the success rate of the implant, one loaded at 30 days after installation and the other at 90 days. Changes in marginal bone level and osseointegration success will be evaluated, with visits and data collection in 0 days (baseline), 30 days, 90 days, 6 months and 1 year
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
In a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will be randomly allocated to receive Temporary restoration after 30 days and definitive restoration after 90 days
In a split-mouth setup, each participant will receive two implants in the posterior region of the mandible or maxilla. After implant insertion, one implant will receive definitive restoration after 90 days
School of Dentistry - University of São Paulo
São Paulo, Brazil
Marginal Bone Loss (MBL)
Digital periapical radiographs will be taken at the implant installation (baseline) after 1 year. The radiographs will be taken using the parallelism technique with a positioner that supports the digital sensor in order to standardize the radiographs.
Time frame: 1 year
Implant success rate
The success rate or failure of each implant in clinical and radiographic findings will be classified using the success criteria defined by Buser et al. (1990) 1. Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysesthesia. 2. Absence of a recurrent peri-implant infection with suppuration. 3. Absence of mobility. 4. Absence of a continuous radiolucency around the implant. 5. Possibility for restoration. These criteria will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Time frame: 1 year
Modified Plaque Index (mPI)
Modified Plaque Index (Mombelli, Van Oosten Et.Al 1987): Scoring Criteria: Score 0: No detection of plaque Score 1:Plaque only recognized by running a probe across the smooth marginal surface of the implant Score 2: Plaque can be seen by the naked eye. Score 3: Abundance of soft matter. The changes in Modified Plaque Index (mPI) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Time frame: 1 year
Modified Bleeding Index (mBI)
Modified Sulcus Bleeding Index (Mombelli, Van Oosten Et.Al 1987): Scoring Criteria: Score 0: No bleeding when probe is passed along the gingival margin. Score 1: Isolated bleeding, spots present. Score 2: Blood forms a confluent red line on margins. Score 3: Heavy or profuse bleeding. The changes in Modified Bleeding Index (mBI) will be monitored by a blinded calibrated examiner at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Time frame: 1 year
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Pocket probing depth (PPD)
Pocket Probing Depth (PPD) will be measured by a blinded calibrated Examiner, and The changes in Pocket Probing Depth (PPD) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Time frame: 1 year
clinical attachment level (CAL)
Clinical attachment level (CAL) will be measured by a blinded calibrated Examiner, and The changes in clinical attachment level (CAL) will be monitored at 0 days (baseline), 30 days, 90 days, 6 months, and the final endpoint is one year
Time frame: 1 year