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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183386
• Other study ID #: SocketRegenerationExp
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2022
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Procedure:
• dental socket regeneration
after a dental extraction the fresh socket is filled with graft materials and compared with the spontaneous healing (control)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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