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

Not Applicable

Completed

• Conditions: Alveolar Bone Loss
• Interventions: Procedure: dental socket regeneration

• Registration Number: NCT05183386
• Lead Sponsor: University of Salamanca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-01-01
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-08
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	dental socket regeneration	Distinct bone graft regeneration strategies (PRGF, Autologous bone and DFDBA)

Primary Outcome Measures

Name	Time	Method
type of bone maturation	2-12 months	Histological Assessment by Goldner Trichromic Stain of the grade of maturation in the regenerated bone inside the alveolar walls
Degree of mineralization	2-12 months	Histological Assessment by Von Kossa Stain of the degree of the mineralization in the regenerated bone inside the alveolar walls