Jaw, Edentulous, Partial Edentulism
Conditions
Keywords
Marginal Bone Loss, Implant depth, Crestal or Subcrestal
Brief summary
The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest
Detailed description
The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest. Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). Patients will be recalled for oral hygiene maintenance and prosthetic controls at 1year, 3 years, 5 years after final restoration.
Interventions
PROCEDURECrestal
Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
PROCEDURESubcrestal
Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Absence of 2-4 teeth in the posterior region of the maxilla or mandibular; 2. Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment; 3. Periodontally healthy.
Exclusion criteria
1. Systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, Paget's disease, and patients with cancer; 2. Uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control; 3. Parafunctional habits, such as the grinding or clenching of teeth; 4. Smoking habit (more than 10 cigarettes per day); 5. Pregnancy and breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal bone loss(MBL) | Change from baseline up to 5 years after implantation | Baseline will be recorded at the time of implantation. Margin bone loss(MBL) will be recorded at 0 day, 4 months, 1 year and 3 years after implant placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative survival rate (CSR) | Up to 5 years after final restoration | Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration |
| Pocket probing depth (PPD) | Up to 5 years after final restoration | Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration |
| Plaque index (PI) | Up to 5 years after final restoration | Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration |
| Bleeding on probing (BOP) | Up to 5 years after final restoration | Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration |
Countries
China
Outcome results
None listed