Bone Density, Bone Level, Immediate Implant Placement, Peri-Implant Tissues, Root Submergence Technique, Single Tooth Lost, Socket Shield Technique Implant Placement
Conditions
Brief summary
The goal of this randomized clinical trial is to compare whether immediate implant placement using the socket-shield technique can better preserve bone density, bone level, and peri-implant tissue health compared to conventional immediate implant placement in patients requiring tooth extraction in the maxillary esthetic zone. This study is conducted in systemically healthy adult patients aged 20-60 years who have non-restorable maxillary anterior teeth indicated for immediate implant placement. The main questions this study aims to answer are: Does the socket-shield technique result in better peri-implant bone density and bone level preservation compared to the conventional immediate implant technique? Does the socket-shield technique lead to improved clinical peri-implant parameters, including probing depth, bleeding on probing, keratinized tissue width, and soft tissue thickness? participants will be divided into two groups: (both groups will receive immediate implant placement of a tooth requiring extraction in the maxillary esthetic zone.) First group: will recieve immediate implant using conventional technique. second group: will recieve immediate implant using socket shield technique. Participants will: * Undergo clinical and radiographic examinations, including cone beam computed tomography (CBCT). * Receive immediate implant placement using either the conventional technique or the socket-shield technique. * Be followed up clinically and radiographically for 9 months to assess bone and soft tissue healing. * Attend regular postoperative and follow-up visits for evaluation of implant stability and peri-implant tissue health.
Interventions
PROCEDUREConventional Technique
Immediate Implant Placement Using Conventional Technique
PROCEDURESocket-Shield Technique
Immediate Implant Placement Using Socket-Shield Technique
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 20 and 60 years of both genders * All participants should be systemically healthy, as assessed using the dental modification of the Cornell Medical Index. * Gingival and periodontal health to be confirmed according to the criteria outlined in the new classification system proposed by Caton et al. (2018). * Presence of non-restorable teeth due to trauma, complicated crowns or root fractures. * Presence of extensive destructive caries making the tooth unsalvageable, particularly in esthetic zones. * Clinical indication for immediate implant placement, especially in cases where minimizing post-extraction bone resorption and soft tissue collapse is critical. * Availability of adequate interocclusal space to accommodate the necessary prosthetic components without occlusal interference.
Exclusion criteria
(for socket-shield technique) * Pregnant female. * Patients with parafunctional habits (e.g., bruxism, clenching). * Smokers. * Teeth with clinical mobility. * Teeth with root fractures extending below the alveolar bone level. * Periodontal ligament space widening. * Signs of internal or external root resorption. * Current or previous periodontal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Density Around Immediate Implants. | At baseline of implant placement then after 9 months | Assessment of bone mineral density using Gray scale values (GSV) derived from Cone Beam Computed Tomography (CBCT) scans. Measurements will be evaluated at the buccal bone adjacent to the retained root fragment (Socket Shield Group) and adjacent to the implant surface (Conventional Immediate Placement Group). The change will be calculated by subtracting the baseline value from the 9-month follow-up value. Unit of Measure: Gray scale values Time Frame: Baseline to 9 months post-implant placement Measure Description: Bone density measured using average gray values extracted from CBCT DICOM files at the buccal aspect of the implant site. Gray scale values reflect the radiographic attenuation/pixel intensity of the surrounding bone. |
| Change in Marginal Bone Level Around Immediate Implants. | At baseline of implant placement then after 9 months. | * Linear measurement of the distance from the implant platform to the first bone-to-implant contact point to assess crestal bone stability. * Unit of measure : Millimeters (mm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Depth (PD) | 3 months, 6 months, and 9 months post-surgery. | Measurement of the distance from the peri-implant mucosal margin to the bottom of the clinical pocket using a calibrated periodontal probe. Unit of Measure: Millimeters (mm) |
| Modified Gingival Index (MGI) | 3 months, 6 months, and 9 months post-surgery. | Assessment of the visual signs of inflammation of the peri-implant soft tissues. Scores range from 0 to 4 (0 = Normal, 1 = Mild inflammation, 2 = Mild inflammation with color change, 3 = Moderate inflammation, 4 = Severe inflammation). Unit of Measure: Score on a scale (0-4) |
| Modified Plaque Index (MPI) | 3 months, 6 months, and 9 months post-surgery. | Assessment of the amount of plaque on the implant/restoration surface. Scores range from 0 to 3 : * 0 = No plaque * 1 = Plaque only recognized by running a probe * 2 = Plaque visible to the naked eye * 3 = Abundance of soft matter). Unit of Measure: Score on a scale (0-3) |
| Gingival Thickness (GT) | Baseline, 3 months, 6 months, and 9 months post-surgery. | Assessment of the thickness of the peri-implant mucosa. This will be measured using a digital caliper or endodontic file with a rubber stopper 2mm apical to the gingival margin. Unit of Measure: Millimeters (mm) |
| Width of Keratinized Tissue (KTW) | Baseline, 3 months, 6 months, and 9 months post-surgery. | Measured from the gingival margin to the mucogingival junction at the mid-facial aspect of the implant site. Unit of Measure: Millimeters (mm) |
Countries
Egypt
Contacts
CONTACTOmar I Wahedi
Outcome results
None listed