Health Condition 1: - Health Condition 2: Y831- Surgical operation with implant ofartificial internal device as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Sponsors
Mr. Abhishek Masalawala
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients aged 18-80 years Patients with single/multiple implants in the anterior esthetic zone Patients with a delayed extraction site and adequate bone volume Patients in whom implants were placed after a defined period of delayed extraction (4-6 months) Patients with healthy gingival tissue without severe periodontal disease Patients evaluated using esthetic assessment tools (Pink Esthetic Score and White Esthetic Score) Informed consent and willingness to adhere to postoperative care
Exclusion criteria
Exclusion criteria: Patients with systemic diseases that could interfere with healing or implant success, including but not limited to diabetes mellitus, arthritis, clotting and bleeding disorders, corticosteroid treatments, chemotherapy, or radiation therapy (within 1 year prior to implantation surgery) Heavy smokers, smoking 6 or more cigarettes per day Chronic alcoholics (consuming alcohol regularly for 10 years) Any other conditions or circumstances, in the opinion of the investigator, which could interfere with the analysis of study results (noncompliance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of adverse events (AEs) including biological events (e.g. redness, bleeding, postoperative pain, discomfort, numbness in nerve distribution areas, peri-implant suppuration and osseous defect, non-integration, flap dehiscence/graft/membrane exposure), adverse device events (ADEs e.g. screw loosening, screw fracture, abutment fracture, implant fracture), and any other AEs reported 3 months after crown placementTimepoint: 1 2 3 Months post Implant | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of oral health at baseline & at 1 2 3 months post-implantation Assessment of postoperative pain using a numeric rating scale (NRS) Analysis of implant stability at 3 months Evaluation of implant prostheses success rate after 3 months of crown placement Evaluation of marginal bone levels at 1 2 3 months post implantation Timepoint: 1 2 3 months | — |
Countries
India
Contacts
Public ContactAnkur Sharma
YMT Dental College and Hospital
Outcome results
None listed