Dental Implant
Conditions
Keywords
immediate implant, maxillary esthetic zone, CTG, jumping gap, bone augmentation
Brief summary
This randomized controlled study is aimed to evaluate the esthetic, clinical, and radiographic outcomes following the placement of immediate single-tooth implant with hard and soft tissue augmentation. Subjects will randomly assigned to one of two groups: * Group A (control group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation only. * Group B (study group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation and connective tissue graft (CTG). The main questions it aims to answer is: Is there is a significant difference in the esthetic outcome between bone augmentation alone and bone augmentation combined with connective tissue graft after immediate dental implant in the esthetic zone?
Interventions
PROCEDUREImmediate dental implant in the esthetic zone
Placement of immediate dental implant after tooth extraction in the maxillary esthetic zone.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a non-restorable tooth or a remaining root without signs of acute infection in the maxillary esthetic zone. * The failing tooth is an incisor, canine or first bicuspid in the maxilla bounded by natural sound teeth. * Sufficient bone (\>4 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥35 N cm). * Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
Exclusion criteria
* Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes). * Teeth with current acute periapical infection. * Dehiscence of the labial (facial) bone plate after extraction. * Signs of uncontrolled periodontal disease. * Heavy smokers and vulnerable groups (pregnant females and decision-impaired individuals). * History of head and neck radiation therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pink Esthetic Score (PES) | Pink esthetic score (PES) will be assessed at 6 months postoperatively. | Seven variables to be scored: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, alveolar process, soft tissue color, and texture of facial gingiva at the implant site. A score of 0, 1, or 2 will be given to each parameter to obtain a final score of 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hard tissue assessment (facial bone thickness) | 6 months postoperatively | Using Cone-Beam Computed Tomography (CBCT) to assess the thickness of the facial (labial/buccal) plate of bone at two points: the implant platform and a point 5mm apical to the implant platform. |
| Patient satisfaction questionnaire | 6 months postoperatively | Assessment of patient satisfaction will be performed at 6 months postoperatively with a self-administered patient questionnaire regarding overall satisfaction and satisfaction of color and shape of the mucosa using a visual analogue scale (VAS, left = very dissatisfied \[0\], right = very satisfied \[10\]. |
| Implant survival rate | 6 months postoperatively | Implant survival rate at 6 months (defined by absence of mobility, infection, pain, and peri-implant bone loss). |
| Rate of complications | From the intervention to 6 month postoperatively | complications such as infection, graft rejection and peri-implantitis will be assessed from the intervention up to 6 months postoperatively. |
Countries
Iraq
Contacts
CONTACTKhalid Khalid, Bachelor of Dental Surgery
Outcome results
None listed