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

U

University of Salamanca

Status

Completed

Conditions

Alveolar Bone Loss

Treatments

Procedure: dental socket regeneration

Study type

Interventional

Funder types

Other

Identifiers

NCT05183386
SocketRegenerationExp

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Control Group
No Intervention group
Description:
The dental socket heals spontaneously
Experimental group
Experimental group
Description:
Distinct bone graft regeneration strategies (PRGF, Autologous bone and DFDBA)
Treatment:
Procedure: dental socket regeneration

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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