Immediate Implant Placement in the Esthetic Zone, NON-RESTORABLE TOOTH IN ESTHETIC ZONE
Conditions
Keywords
Bone Grafting, Alveolar Ridge, Jumping Gap, Esthetic Zone, Xenograft, Hyaluronic Acid, Immediate Implant Placement
Brief summary
This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of immediate implant placement using xenograft combined with hyaluronic acid versus xenograft alone in the esthetic zone. Patients requiring extraction of a non-restorable tooth followed by immediate implant placement will be randomly allocated to two groups. In the intervention group, the jumping gap between the implant and facial bone wall will be grafted with xenograft combined with hyaluronic acid, while in the control group, xenograft alone will be used. The primary outcome is the radiographic change in the labio-palatal ridge width. Secondary outcomes include pink esthetic score, implant stability, crestal bone loss, and the amount of bone labial to the implant. Patients will be followed for up to 12 months postoperatively.
Interventions
PROCEDUREImmediate implant placement
Immediate implant placement following atraumatic tooth extraction in the esthetic zone.
BIOLOGICALXenograft
Xenograft bone graft material used to fill the jumping gap around the immediately placed implant
DRUGHyaluronic Acid (0.2%)
Hyaluronic acid gel (0.2%) combined with xenograft for filling the jumping gap around the immediately placed implant.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome evaluators and data analysts will be blinded to group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-restorable tooth in the esthetic zone. * Thin labial plate of bone (≤1 mm) maintained after tooth extraction. * Teeth with no acute inflammation. * Thick soft tissue biotype. * Patients free from any systemic condition that may affect the healing. * Availability of bone apical and palatal to the socket to provide primary stability for the immediate implant (Morton et al. 2014). * Good oral health. * Willingness to sign the informed consent form. * Adult patients more than 18 years of age.
Exclusion criteria
* Heavy smoker (\>10 cigarettes/day) (Lambert et al. 2000). * Pregnant females. * Contraindication for implant surgery. * Patients with poor oral hygiene. * Acute inflammation in the site of implantation and adjacent tissue. * A history of radiotherapy in the head or neck region. * Patients with systemic disease like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation (Wu et al. 2019).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic change in labial bone thickness | Baseline and 12 months postoperatively | Radiographic change in labio-palatal ridge width at 0, 2 and 5 mm from the crest of bone labial to the implant, assessed using CBCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pink Esthetic Score (PES) | 6 and 12 months postoperatively | Esthetic evaluation using the Pink Esthetic Score (PES). Seven variables are evaluated: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. A 0-1-2 scoring system is used, with 0 being the lowest and 2 being the highest value for each parameter. The maximum achievable PES is 14. |
| Implant Stability | 6 and 12 months postoperatively | Implant stability will be measured using Osstell, which has a scale range from 1 to 100; the higher the ISQ, the more stability. |
| Crestal Bone Loss | Baseline and 12 months postoperatively | Crestal bone loss will be evaluated using CBCT at two time points. Vertical crestal bone-level changes will be measured and standardized to assess bone-level changes around the implant. |
| Amount of Bone Labial to the Implant | 1 year postoperatively | The amount of bone formed labial to the implant will be measured at three levels below the labial bone crest: 0 mm, 2 mm and 5 mm, using CBCT. |
Countries
Egypt
Outcome results
None listed