Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055311) titled 'OSSEOINTEGRATION ANALYSIS OF "MERAH PUTIH" DENTAL IMPLANT FROM CLINICAL & RADIOGRAPHY OBSERVATION: A CLINICAL PILOT STUDY' on Aug. 22.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran
Condition:
Condition - Partial edentulism of the mandible with no history of smoking & systemic condition
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Purpose of this study is to evaluate the initial efficacy assessment of novel dental implant ("Merah Putih" dental implant) from osseointegration process and its safety in human alveolar bone.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Subjects will have dental implant procedure with standard osteotomy technique for dental implant using selected drilling sequences in posterior mandible. Following osteotomy procedure, the novel dental implant in this study with the size of 4 mm in diameter and 10 mm in length is inserted into the site (0,5 mm to 1 mm submerged in alveolar bone) with selected drilling sequences. The neck of dental implant is covered with cover screw that comes along with the dental implant. Suturing of the dental implant is conducted so the evaluation of its osseointegration process inside the alveolar bone can be done for at least 3 months following the dental implant procedure. Subjects will be instructed to have control visits in 3, 7, 14 days and 4,8,12 weeks for clinical and radiography assessment. The result of 12 weeks observation will be determined from clinical and radiography parameters (bone density & bone to implant contact measurement).
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Male/Female subjects who give consent for the intervention.
2. Edentulism condition of posterior mandible more than 4 months after tooth extraction.
3. Alveolar bone volume is adequate for dental implant with the size of 4 mm in diameter and 10 mm in length.
4. Good oral hygiene control (O'leary plaque index less than 20%).
5. The interocclusal distance of the edentulous is adequate for dental crown (minimum of 7 mm).
Key exclusion criteria - 1. Subjects with smoking habit.
2. Subjects with pregnancy and breastfeeding condition.
3. Subjects with systemic diseases (diabetes, osteoporosis, hypertension, arthritis, hypothyroidism, parathyroidism, and blood disorders).
4. Subjects with routine antibiotics, anti-inflammation, biphosphonates, hormone replacement therapy, and corticosteroid drugs consumption 6 months prior to dental implant procedure.
5. Subjects with history of alveolar bone augmentation at implant site 6 months prior to dental implant procedure.
6. Subjects with history of tooth extraction 3 months prior to dental implant procedure.
7. Subjects with the needs of bone/soft tissue grafting at dental implant insertion.
8. Subjects with physical disorders that are able to interfere the oral hygiene maintenance.
9. Subjects with history of head & neck radiotherapy.
10. Subjects with bad oral habit (bruxism & clenching).
Target Size - 7
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 08 Month 19 Day
Date of IRB - 2024 Year 08 Month 19 Day
Anticipated trial start date - 2024 Year 08 Month 22 Day
Last follow-up date - 2024 Year 11 Month 14 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063210
Disclaimer: Curated by HT Syndication.
