This is a post-market prospective observational study to prospectively collect clinical data to confirm the long-term safety and clinical performance of implants and abutments Helix Short in a daily dental practice setting, by means of success and survival rates of these devices. Additionally, from the collected data, the study aims to identify previously unknown side-effects and monitor the known side-effects and contraindications stated on the IFU, identify and analyze emerging risks on the basis of factual evidence, and ensure the continued acceptability of the benefit-risk ratio with the intent to verify that the intended purpose is correct for all JJGC products involved in the procedure that get in contact with the patient.
Study Type
OBSERVATIONAL
Enrollment
94
Dental Implant placement and loading.
Implant success rate
Implant success rate (including survival as one of the criteria for success) of implants at 3 years after implant loading.
Time frame: From the implant loading to the 36-months of follow-up
Implant survival rate
Implant survival rate
Time frame: From the implant loading to the 36-months of follow-up
Prosthetic survival and success rates
Prosthetic results
Time frame: From the implant loading to 36-months of follow-up
Change in peri-implant bone level
Evaluating bone loss
Time frame: From the implant loading to 36-months of follow-up
Soft tissue assessment - Visible Plaque
Visible plaque index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting visible plaque.
Time frame: From the implant loading to 36-months of follow-up
Evaluation of the crown/implant ratio
Evaluation of the crown/implant ratio
Time frame: From the implant loading to 36-months of follow-up
Risk factors for Implant Loss
Risk factors for implant loss will be assessed performing statistical analysis between implants losses and characteristics of these losses (implant and procedures' characteristics).
Time frame: From the enrollment to 36-months of follow-up
Type of load and time for final prosthesis
If immediate or late loading.
Time frame: From the implant placement to 36-months of follow-up
Patient satisfaction
Patient satisfaction assessment through (Oral Health Impact Profile-14) questionnaire. It is made of 14 questions to be answered through a set of Likert scale. The final score is calculated based on the answers for each question, and it is ranged from 0 to 56. The highest score indicates a greater negative impact of oral health on a person's well-being. The questions include seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and social disadvantage. The questionnaire will be applied in different times of follow-up during the study.
Time frame: From the enrollment to 36-months of follow-up.
Clinician satisfaction with all devices used and procedures
Clinician satisfaction assessment through a questionnaire about implant placement and rehabilitation outcomes, and the answers through a visual analogue scale (VAS) from 1 to 10. The highest scores means better outcome.
Time frame: From the implant placement to 36-months of follow-up.
Adverse events and residual risks related to the implant, prosthetic component, and prosthesis.
Monitoring of adverse events, including implant and prothesis loss to evaluate their association with implant's and patient's charactheristics.
Time frame: From the enrollment to 36-months of follow-up.
Soft tissue assessment - Marginal Bleeding Indexes
Marginal bleeding index will be calculated for each implant site as the percentages of surfaces (mesial, buccal, distal, lingual) presenting marginal bleeding.
Time frame: From the implant loading to 36-months of follow-up
Soft tissue assessment - Bleeding on probing
Bleeding on probing will be assessed as present or absent, using a periodontal probe to the bottom of the clinical sulcus, in the buccal surface of each implant site. Bleeding will be considered positive if it occurs within 10 to 15 seconds after probing.
Time frame: From the implant loading to 36-months of follow-up
Soft tissue assessment - Keratinized gingiva
Calibrated probes of 1, 2, 3, 5, 7, and 10 mm will be used to measure the range of keratinized gingiva as the distance from the gingival margin to the mucogingival junction, at the center of the buccal surface. The thickness of the keratinized tissue will be assessed and categorized as thick or thin. This assessment will be based on the transparency of the same periodontal probe through the gingival margin during the probing of the sulcus in the mid-buccal region. If the outline of the underlying periodontal probe could be seen through the gingiva, it was classified as thin (score: 0); otherwise, it was classified as thick (score: 1)
Time frame: From the implant loading to 36-months of follow-up
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