Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina in the Esthetic Zone.

N/ANot Yet RecruitingNCT07800377

Mansoura University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type II Extraction Sockets in the Esthetic Zone

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Facial Bone Dimensional Changes

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.

Time frame: Immediately after surgery (T0) and 6 months (T6)

Secondary Outcomes

Soft Tissue Volumetric Changes

Assessed by superimposition of intraoral scan STL files obtained at baseline and 6 months postoperatively.

Time frame: Baseline and 6 months postoperatively

Implant Stability

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.

Time frame: Immediately postoperatively, 3, and 6 months postoperatively.

Pink Esthetic Score (PES)

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.

Time frame: 6 months postoperatively.

Patient-reported Esthetic Satisfaction

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.

Time frame: 6 months postoperatively

Surgical Time

Recorded in minutes from the start of the surgical procedure until completion.

Time frame: During the surgical procedure

Postoperative Complications

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.

Time frame: 1 week, 1 month, 3 months, and 6 months postoperatively