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Completed

NCT Number: NCT05183386

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

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.

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dental socket regeneration

Procedure

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

Primary outcomes

  1. Degree of mineralization

    Time frame: 2-12 months

    Histological Assessment by Von Kossa Stain of the degree of the mineralization in the regenerated bone inside the alveolar walls

  2. type of bone maturation

    Time frame: 2-12 months

    Histological Assessment by Goldner Trichromic Stain of the grade of maturation in the regenerated bone inside the alveolar walls

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jan 10, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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