A randomized controlled clinical study comparing and observing hard tissue and soft tissue changes in bone loss observed around implants when bone grafting using two different powdered bone graft materials was performed.
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008393
- Lead Sponsor
- Yonsei University Health System, Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1. Periodonally healthy adult men and women aged 18 years or older
2. Good oral hygiene (plaque index <25% in the entire jaw) (O'Leary et al. 1972)
3. The level of inflammation control is adequate (bleeding on probing of the anterior jaw <25%) (Ainamo & Bay 1975)
4. Those who need to place 1 or 2 implants in the edentulous area where 1 or 2-3 teeth are continuously lost
5. A person who has one or more dehiscence defects of 3 mm or more in the apico-coronal direction around the fixture after implant placement
6. A person who can achieve sufficient fixation during implant placement (determined during implant surgery)
7. If more than 3 months have passed since tooth extraction
8. Cases where soft tissue transplantation is not required after implant placement
1. A person who has undergone hard tissue or soft tissue transplantation within the last 6 months
2. Those who smoke more than 10 cigarettes a day
3. Drugs that cause soft tissue hypertrophy (e.g., diuretics, immunosuppressants, antiepileptics) or drugs that interfere with bone formation (e.g., corticosteroids) within 2 weeks of screening, or may be taken during the clinical trial person with
4. Those who have administered oral or injection rheumatism treatment within 2 weeks from the time of screening
5. Patients with uncontrolled diabetes or hypertension
6. Those with skin diseases or lesions in the oral cavity (e.g., erosive lichen planus, erosive lichen planus, stomatitis, ulcers, malignant tumors)
7. Those suffering from systemic diseases related to bone metabolism such as osteomyelitis
8. Those who have been or are currently taking oral or injectable bisphosphonate medicines for osteoporosis for more than 3 months (However, according to AAOMS, those who have stopped taking medication for more than 3 months and have CTx level of 0.150ng/ml or higher participate in clinical research) possible)
9. Those who have a history of tumor removal at the surgical site
10. Subjects with Full Mouth Plaque Score and Full Mouth Bleeding Score of 25% or higher
11. A person with an apical or purulent apical lesion on an adjacent tooth
12. Those who lack oral hygiene management skills
13. Those who have received radiation therapy or chemical therapy under the diagnosis of a malignant tumor within the past 5 years
14. Persons with mental illness that significantly affects this clinical trial
15. Pregnant or Nursing Mothers
16. In addition to the above, those who have clinically significant findings that are considered inappropriate for this study as determined medically by the principal investigator or person in charge
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method implant survival rate
- Secondary Outcome Measures
Name Time Method Plaque index (PI) (Silness and Loe, 1964 (Silness & Loe 1964)). The four sides of the adjacent tooth and implant are evaluated as 0-3 points.;Probe pocket depth (PPD) of adjacent teeth is measured at 6 locations (mesiobuccal, buccal medial, distal buccal, distal lingual, distal lingual, mesial lingual) using a UNC-15 periodontal probe with a force of 0.2-0.3 N. (Examiner M.H. was calibrated in advance).;Bleeding Index on Probing (BOP);Width of keratinized gingiva (mm);Evaluation of hard tissue changes in the bone defect area using radiographic methods;Evaluation of changes in buccal soft tissue volume around implants through intraoral scan;OHIP-14