Peri-implant Tissue Response With Use of Customized Healing Abutments
Conditions
Keywords
dental implant, customized healing abutment
Brief summary
The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is: • effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.
Detailed description
Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.
Interventions
PROCEDUREcustomized healing abutment
patients will undergoes one-stage implant placement with customized healing abutments with different macrogeometry and emergence angle made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.
PROCEDUREstandard healing abutment
patients will undergoes one-stage implant placement with standard titanium healing abutment made prior to the surgery and will be inserted without sutures, after osseointegration completed patients will received single crown on implant.
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
patients in each group will received different types of customized healing abutment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥18 years of age; * patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions * sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration; * had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm.
Exclusion criteria
* medical and general contraindications for the surgical procedure; * heavy smokers (\>10 cigarettes/day); * an active infection at the implant site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| soft tissue alteration | T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up | peri-implant soft tissue change compared to baseline including vertical and horizontal soft tissue alteration by superimposing intraoral scan at different time points |
| hard tissue alteration | T0 baseline before implant placement, 6month follow up, 12month follow up | peri-implant marginal bone change compared to baseline at different time points by periapical radiograph |
| volumetric alteration | T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up | peri-implant volumetric change at different time points compared to baseline with superimposing intraoral scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain numerical rating scale | at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery | pain assessment at time of final prosthesis delivery with scale from 0 to 10 |
| pink esthetic score | T0 baseline before implant placement, 6 month follow up | pink esthetic score change compared to before implant treatment |
Countries
Thailand
Outcome results
None listed