Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques

Study Overview
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Brief Summary
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The aim is to comparatively evaluate the soft tissue volume changes that occur after tooth extraction and immediate dental implant placement using two different surgical techniques. These techniques are: the Socket-Shield technique and conventional immediate placement. The null hypothesis is that the Socket-Shield technique better maintains soft tissue volume after partial tooth extraction and immediate implant placement compared to the conventional technique. From a sample of 30 patients, they will be divided into groups of 10 and will be randomized using the random.org program. The volume of the soft tissues will be recorded by means of a hydrocolloid impression before tooth extraction and 6 months later. The soft tissue dimensional changes produced will be digitally evaluated and statistically analyzed.

Detailed Description
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After tooth extraction, the supporting tissues, bone and mucosa will undergo a loss of volume associated with the loss of the cementum-periodontal ligament-bone attachment complex. This alteration in volume can affect aesthetic results, especially when the tooth involves the anterior area, where the alveolar bone is narrower. To compensate for the lost volume loss, some authors promote delayed implant placement, which would facilitate soft tissue management after healing. The conventional immediate implant placement technique proposes the use of bone regeneration biomaterials in the space between the implant wall and the residual vestibular bone. The aim of this technique is to compensate for this bone resorption, thus improving the aesthetic results. In the same sense of compensating for the resorption that will occur, some authors recommend the use of soft tissue grafts in the same operative act of extraction and placement of the immediate implant. Some years ago, some authors presented the technique of partial extraction of the tooth as an alternative to the conventional technique of immediate implant placement after extraction with the aim of avoiding or minimising this resorption. The technique consists of leaving a piece of tooth (shield) inserted in the vestibular alveolar bone area so that the resorption process is slowed down. The presence of bone between the dentine wall of the tooth fragment and the implant has been demonstrated in both animal and ex-vivo histological studies. From a clinical point of view, the Socket-Shield or partial extraction technique has been shown to maintain the vestibular volume in post-extraction implants placed using this technique in both posterior and anterior areas with high aesthetic compromise, maintaining adequate clinical values and patient satisfaction. On the other hand, a 2015 systematic review, comparing immediate and delayed implantation techniques, reports no significant differences between the two, especially at the soft tissue level, although it mentions a lack of quality in the RCTs analysed. A 2017 randomized clinical trial compared the conventional immediate implant placement technique with the delayed or early implantation technique, advising against the former when aesthetics were compromised and limiting it to well-selected cases. In contrast, another more recent randomized clinical trial found no aesthetic, clinical or radiographic differences between the two techniques, and reported similar levels of patient satisfaction. Likewise, a higher rate of early failure has been found in the immediate implantation technique, mentioning the lack of randomised clinical studies comparing both techniques, especially in terms of soft tissue volume changes. A recent randomised clinical study comparing the Socket-Shield technique with the conventional implant placement technique found better levels of marginal bone and pink aesthetic assessment in the former, considering it a safe and feasible technique in the anterior sector. Given the lack of evidence in the literature, there is a palpable need for clinical studies to compare the best technique and/or timing of implant placement after tooth extraction.

Official Title
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Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques: Randomized Comparative Study.

Conditions
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Dental Implant, Tooth Extraction, Bone Resorption

Intervention / Treatment
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* Procedure: Dental implant placement after tooth extraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring single tooth extraction in lateral or anterior areas of the upper jaw. Teeth that do not present alteration or loss of the vestibular bone table. Exclusion Criteria: Patients in whom surgical intervention is contraindicated. Teeth with alteration or loss of the vestibular bone table. Teeth with marginal recession >2mm. Early or delayed failure of the implant placed with any of the three techniques.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 10 receiving immediate implant placement with Socket-Shield Technique and 10 receiving immediate implant placement with complete extraction of the tooth. (n=20)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Implant with SST (SST)<br>Patients who will receive immediate implant placement using the Socket-Shield Technique. | Procedure: Dental implant placement after tooth extraction<br>* Immediate implant placement after partial or complete tooth extraction.<br>* Other names: Implant surgery;|
| Active Comparator: Immediate Implant with biomaterial (GAP)<br>Patients who will receive immediate implant placement using bone biomaterials to fill the gap after complete extraction of the tooth. | Procedure: Dental implant placement after tooth extraction<br>* Immediate implant placement after partial or complete tooth extraction.<br>* Other names: Implant surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue volume | Soft tissue volume changes after tooth extraction | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery pain perception by Numerical Rating Scale | Pain perception by the patient during surgical procedure, being 0 no pain at all, 1-3 mild discomfort, 4-7 moderate pain and 7-10 intense pain. | Just after surgery | 
| Surgery satisfaction of the patient by Numerical Rating Scale | Patients satisfaction after surgery, being 0 not satisfied at all, and 10 very satisfied | Just after surgery | 
| General satisfaction of the patient by Numerical Rating Scale | Patients general satisfaction 6 months after the beginning of treatment, being 0 not satisfied at all, and 10 very satisfied | 6 months after the beginning of treatment | 
| Esthetic satisfaction of the patient by Numerical Rating Scale | Patients esthetic satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied | 3 months after after crown placement | 
| Function satisfaction of the patient by Numerical Rating Scale | Patients function satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied | 3 months after after crown placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postextraction implant, Implant type 1, Socket-Shield, Soft Tissue volume, RCT