Type II Extraction Sockets in the Esthetic Zone
Conditions
Keywords
Vestibular Socket Therapy, VST, Type II Extraction Sockets, Immediate Implant Placement, Magnesium Membrane, Cortical Lamina, Esthetic Zone, Facial Bone
Brief summary
This randomized clinical trial aims to compare two membrane materials used in Vestibular Socket Therapy (VST) technique during immediate implant placement in Type II extraction sockets in the esthetic zone. A total of 30 patients will be randomly allocated to receive VST using either a biodegradable magnesium membrane or a cortical lamina membrane. Both groups will receive immediate implant placement and xenogeneic bone graft. The study will compare changes in facial bone dimensions, soft tissue volume, implant stability, pink esthetic score, patient satisfaction, surgical time, and postoperative complications over a 6-month follow-up period.
Interventions
PROCEDUREVestibular Socket Therapy Using Magnesium Membrane
Vestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
PROCEDUREVestibular Socket Therapy Using Cortical Lamina
Vestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be stratified according to extraction socket subtype and randomly assigned in a 1:1 ratio to receive Vestibular Socket Therapy using either a biodegradable magnesium membrane or a cortical lamina membrane.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 45 years. 2. Requirement for extraction of one or more teeth in the maxillary esthetic zone with Type II extraction sockets. 3. Presence of adequate palatal and apical bone to achieve primary implant stability. 4. Adequate interocclusal restorative space for implant-supported prosthetic rehabilitation. 5. Good oral hygiene and satisfactory plaque control
Exclusion criteria
1. Acute infection at the intended implant site (e.g., acute abscess or cellulitis). 2. Uncontrolled systemic diseases or medical conditions that may compromise bone healing or osseointegration. 3. History of irradiation to the head and neck region within one year before implant placement. 4. Alcohol or drug abuse. 5. Pregnancy or lactation. 6. Parafunctional habits such as bruxism or clenching. 7. Current smoking or tobacco using. 8. Poor oral hygiene or inability to maintain adequate plaque control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial Bone Dimensional Changes | Immediately after surgery (T0) and 6 months (T6) | CBCT scans obtained immediately after surgery (T0) and at six months (T6) will be superimposed using OnDemand3D software. The following parameters will be assessed: facial bone thickness at the crestal level, facial bone thickness at the middle level, facial bone thickness at the apical level, and facial bone height. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soft Tissue Volumetric Changes | Baseline and 6 months postoperatively | Assessed by superimposition of intraoral scan STL files obtained at baseline and 6 months postoperatively. |
| Implant Stability | Immediately postoperatively, 3, and 6 months postoperatively. | Assessed using radiofrequency analysis (RFA) using an Osstell Mentor Device. A SmartPeg will be attached to each implant, and resonance frequency measurements will be recorded in four directions (every 90°). The obtained values will be expressed as Implant Stability Quotient (ISQ) scores, and the mean ISQ value for each implant will be used for statistical analysis. The Implant Stability Quotient (ISQ) ranges from 1 to 100, with higher scores indicating greater implant stability. |
| Pink Esthetic Score (PES) | 6 months postoperatively. | The Pink Esthetic Score (PES) assesses peri-implant soft tissue esthetics using seven parameters, each scored from 0 to 2, for a total score of 0-14. Higher scores indicate better esthetic outcomes. Assessed using standardized clinical photographs. |
| Patient-reported Esthetic Satisfaction | 6 months postoperatively | Assessed at 6 months using a 100-mm Visual Analog Scale (VAS), where 0 indicates complete dissatisfaction and 100 indicates complete satisfaction with the esthetic result. |
| Surgical Time | During the surgical procedure | Recorded in minutes from the start of the surgical procedure until completion. |
| Postoperative Complications | 1 week, 1 month, 3 months, and 6 months postoperatively | Recorded throughout the follow-up period and evaluated at 1 week, 1 month, 3 months, and 6 months postoperatively for the occurrence of membrane exposure, wound dehiscence, infection, graft loss, and implant failure. |
Countries
Egypt
Outcome results
None listed