Histological Outcome of the Use of Different Biomaterials for Fresh Socket Regeneration. A Split-mouth Design

Study Overview
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Brief Summary
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Purpose: The aim of this study was to analyze the quality of bone regeneration in fresh sockets using four different materials and at different times points. Materials and Methods: A split-mouth clinical trial was designed to evaluate the histological and histomorphometrical characteristics of fresh sockets from 30 patients. One socket per patient will healed spontaneously (control) and, at least, one fresh socket, will be grafted with platelet-rich growth factor (PRGF), PRGF+autologous bone, autologous bone or PRGF+demineralized freeze dried bone allograft (DFDBA). The day of the implant placement, biopsies will be taken at different time points divided into three assessment groups: short duration (2-4 months), intermediate duration (5-6 months) and long duration (7-12 months). The histologic findings will be assessed to quantify the trabeculae pattern, the degree of mineralization and the quality of bone regeneration.

Official Title
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Histological Outcome of the Use of Different Biomaterials for Fresh Socket. A Split Mouth Design

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Procedure: dental socket regeneration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in need of at least one bilateral tooth extraction due to one or more of the following causes: periodontal disease, vertical fracture included teeth. Patients seeking dental implant to replace their missing teeth. All sockets should have intact or partially conserved buccal wall according to Elian´s classification (Type I, II). Exclusion Criteria: Patients under 18 years old. Patients with a severely untreated periodontal disease. Smokers of more than 15 cigarettes a day. patients suffering from any systemic disease requiring pharmacological treatment. Patients whose socket´s buccal wall is totally missing after tooth extraction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The dental socket heals spontaneously | |
| Experimental: Experimental group<br>Distinct bone graft regeneration strategies (PRGF, Autologous bone and DFDBA) | Procedure: dental socket regeneration<br>* after a dental extraction the fresh socket is filled with graft materials and compared with the spontaneous healing (control)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of mineralization | Histological Assessment by Von Kossa Stain of the degree of the mineralization in the regenerated bone inside the alveolar walls | 2-12 months | 
| type of bone maturation | Histological Assessment by Goldner Trichromic Stain of the grade of maturation in the regenerated bone inside the alveolar walls | 2-12 months |