Clinical trial of multiple implant restoration using narrow-diameter implants in anterior region of the lower jaw

Clinical and Radiological Evaluation of Narrow Diameter Implant for Fixed Prosthesis in mandibular anterior multiple teeth loss: Randomized Controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007300

Enrollment

Registered

2022-05-18

Start date

2021-04-12

Completion date

Unknown

Last updated

2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : One of the following implants will be placed randomly at the extraction site of multiple teeth in the mandibular anterior teeth. Two implants will be placed for each patient. experim

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Adult over 19 years old -Those who need to extract two or more mandibular central incisors or/and lateral incisors and implant restoration -Periodontal healthy at the adjacent natural teeth -The distance between the implants is 3mm or more, and the distance between the implant and the tooth is 1.5mm or more -Adequate bone quantity to obtain primary stability with F 3.2mm, F 3.3mm, F 3.5mm diameter implants

Exclusion criteria

Exclusion criteria: - Extensive acute infection due to periodontal disease - Extensive bone destruction due to periodontal disease -Pregnant or lactating women -Uncontrolled metabolic systemic disease (high blood pressure, diabetes) -Subjects with a history of radiation irradiation therapy or chemotherapy in the head and neck area -Subjects with serious cardiovascular disease, respiratory system disease, kidney disease, liver disease, digestive system disease, blood system disease, and neuropsychiatric diseases -Subjects with hyperthyroidism or hypothyroidism -Subjects with a history of drug allergy -Subjects who have a high degree of depression or anxiety disorder and are judged to have an influence on the evaluation of the clinical trial -Subjects who have a history of or currently abuse drugs or alcohol within one year -Subjects with a history of taking Bisphosphonate drugs within 4 months -Smokers with more than one pack (20) per day -Unstable occlusal stop -Subjects who are judged to be unsuitable for the subject of the study by the researcher

Design outcomes

Primary

Measure	Time frame
implant success rate	—

Secondary

Measure	Time frame
implant survival rate;patient satisfaction;Pink Esthetic Score;White Esthetic Score;peri-implant marginal bone loss;Oral Health Impact Profile (OHIP)-14;clinical index (probing, modified plaque index, modified sulcus bleeding index)	—

Countries

Korea, Republic of

Contacts

Public ContactJungWon Lee

Seoul National University Dental Hospital

leejungwon95@naver.com+82-2-2072-3034

Outcome results