Investigation of biomarkers of alveolar bone stem cells for bone stability prediction around implants

Not Applicable

Completed

Conditions: Diseases of the digestive system

Registration Number: KCT0002425

Lead Sponsor: Yonsei University Health System, Dental Hospital

Brief Summary: (1)Information on the subject · Target number of study subjects : 50 · Number of subjects in the observation group : 37 · Number of subjects who completed the research procedure: 31 (98 implants) · Number of subjects to be dropped out : 6 · Presence or absence of serious adverse events, including serious adverse events during the study : none · Number of subjects by sex / age Age (years) Sex Total Male Female 21~30 1 1 2 31~40 1 1 2 41~50 2 5 7 51~60 9 1 10 61~ 4 6 10 Total 17 14 31 (2) Information on research outcomes 1) Primary Outcome a) Analysis of Stem cell characteristics of alveolar bone stem cells The stem cell biomarkers used for the Real-time PCR analysis are as follows. (1)Osteogenesis (OC,OPG,ALPL,Runx-2,BMP-2,BSP,Osteopontin) (2)Osteoclastogenesis (RANKL,ICAM-1,M-CSF,IL-1,IL-7) (3)Adipogenesis (LPL,FABP4,PPAR?-2) (4)Tissue healing (VEGF,TGF-ß,HGF,SDF-1,EGF,IL-6) (5)House keeping (GAPDH) b) Short-term clinical and radiographic evaluation of osseointegration and bone remodeling of dental implants None of the implants failed among patients evaluated over the entire study period, representing a 100% survival rate. The peri-implant bone loss (n=98) was 0.04±0.13 mm at the 3-month follow-up and 0.30±0.61 mm at the 1-year follow-up. c) Correlation between Stem Cell Biomarker and Clinical stability of dental implants There were statistically significant differences in the runt-related transcription factor-2 (Runx-2) and bone morphogenetic protein-2 (BMP-2) osteogenesis-related genes, and in the peroxisome proliferator-activated receptor gamma-2 (PPAR?-2) adipogenesis-related gene and the receptor activator of nuclear factor ? ligand (RANKL)/osteoprotegerin (OPG) ratio between the groups with and without marginal bone loss. 2) Secondary Outcome a) Patient-related factors (Age, Sex, Involved jaw, Implant position, Bone quality) b) Implant- or prosthesis-related factors (Implant diameter, Implant length, Insertion torque, Initial ISQ, Implant placement depth, GBR procedure, Type of suprastructure) Variable type Variable No. of implants Implants with peri-implant bone loss Host-related Age (years) =60 63 4 (6.35%) >60 35 5 (14.29%) Sex Male 53 4 (7.55%) Female 45 5 (11.11%) Involved jaw Mandible 41 1 (2.44%) Maxilla 57 8 (14.04%) Implant location Posterior 82 4 (4.88%) Anterior 16 5 (31.25%) Bone quality D2 41 4 (9.76%) D3 39 1 (2.56%) D4 18 4 (22.22%) Implant- or prosthesis-related Implant diameter Narrow 3 1 (33.33%) Regular 95 8 (17.22%) Implant length Short 35 1 (2.86%) Long 63 8 (12.70%) Insertion torque (N) >20 85 9 (10.59%) =20 13 0 (0%) Initial ISQ =70 75 8 (10.67%) <70 23 1 (4.35%) Implant placement depth Crestal 27 4 (14.81%) Subcrestal 71 5 (7.04%) GBR procedure No 81 7 (8.64%) Yes 17 2 (11.76%) Type of suprastructure SC 53 0 (0%) FPD 29 1 (3.45%) OD 16 8 (50.00%)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

1. Patient who needs implant treatment due to tooth loss
2. Patients who do not require bone grafting becaus of sufficient bone

Exclusion Criteria

1. Pregnant woman
2. Patients with systemic diseases such as uncontrolled hypertension and diabetes
3. Drugs that can cause systemic effects (nifedipin, phenytoin, cyclosporine)
4. Smoking (former smoker excluded for more than 10 years) and other systemic diseases

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of stem cell and biological characteristics of alveolar bone stem cells isolated from alveolar bone piece during implant drilling;Short-term clinical evaluation of implant osseointegration and bone remodeling;Short-term radiographic evaluation of implant osseointegration and bone remodeling

Secondary Outcome Measures

Name	Time	Method
The host-related variables (sex, age, involved jaw, implant location, bone quality);Implant-prosthesis-related variables (implant diameter, length, insertion torque, initial implant stability quotient (ISQ), depth of implant placement, presence of GBR procedure, type of suprastructure