Clinical study comparing short-diameter implants with 3.5 mm diameter to long-diameter implants with 5.0 mm diameter for implant placement

Evaluation of clinical efficacy of narrow diameter Dentium Bright Tissue-level impant system placed in the molar area: A randomized controlled clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009415

Enrollment

Registered

2024-05-10

Start date

2024-05-16

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

None listed

Interventions

Procedure/Surgery : - Total: 20 participants (20 from Yonsei University Department of Periodontics) - Experimental group (NDI group

10 patients): Dentium BTLI FX35 (3.5 mm in diameter) implanted - Control group (WDI group

10 patients): Dentium BTLI FX50 (5.0 mm diameter) implanted

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. adults 20 years of age or older 2. 1 or 2 implants to be placed in the edentulous areas of the maxillary or mandibular maxillary or mandibular premolars 3. 2 months or more have passed since tooth extraction in the area where the implants are to be placed

Exclusion criteria

Exclusion criteria: 1. minors under the age of 20 2. severe lack of bone mass in the maxillary or mandibular palatal region, making implant placement difficult 3. patients with uncontrolled metabolic systemic diseases (e.g., diabetes, etc.) 4. patients with a history of irradiation therapy and chemotherapy of the head and neck 5. smokers of more than one pack per day 6. heavy smoker (more than one pack per day) 7. pregnant/ breastfeeding Patients with a history of previous tumor removal in the same area 8.

Design outcomes

Primary

Measure	Time frame
Buccal resorption of implant marginal bone	—

Secondary

Measure	Time frame
Results of an assessment of placement accuracy in computer-guided surgery;Implant success rate;Whether valve incisions and additional surgeries were performed during implant placement and whether mechanical or biological complications occurred.;Implant survival rate;Changes in peri-implant mucosal height assessed with intraoral scan data;Treatment time from implant surgery to prosthetic completion;Implant stability at the time of prosthesis placement and 6 months after prosthesis placement (Easycheck, ISQ);Operator satisfaction survey results: Aspects such as surgery time, difficulty of treatment.;Patient satisfaction survey results: Postoperative pain, duration of surgery, cost of care, ease of mastication.;Whether a valve incision was made during implant placement and whether additional surgery (such as bone grafting) was performed.	—

Measure

Time frame

Results of an assessment of placement accuracy in computer-guided surgery;Implant success rate;Whether valve incisions and additional surgeries were performed during implant placement and whether mechanical or biological complications occurred.;Implant survival rate;Changes in peri-implant mucosal height assessed with intraoral scan data;Treatment time from implant surgery to prosthetic completion;Implant stability at the time of prosthesis placement and 6 months after prosthesis placement (Easycheck, ISQ);Operator satisfaction survey results: Aspects such as surgery time, difficulty of treatment.;Patient satisfaction survey results: Postoperative pain, duration of surgery, cost of care, ease of mastication.;Whether a valve incision was made during implant placement and whether additional surgery (such as bone grafting) was performed.

—

Countries

Korea, Republic of

Contacts

Public ContactJoo-Yeon Lee

Yonsei University Health System, Dental Hospital

dlwndus34@naver.com+82-2-2228-2953

Outcome results