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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.

Healing pattern of peri-implant dehiscence defects around implants with chemically modified SLA surface: A randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008393
Enrollment
50
Registered
2023-04-28
Start date
2018-12-24
Completion date
Unknown
Last updated
2024-04-02

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 : Individuals who voluntarily sign the informed consent form and meet the selection criteria have been enrolled in this clinical study. Test subjects are randomly assigned to the exp

Sponsors

Yonsei University Health System, Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
implant survival rate

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactJOO YEON LEE

Yonsei University Health System, Dental Hospital

dlwndus34@naver.com+82-2-2228-8825

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 5, 2026