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

NCT05183386 | Completed

• 1 other identifier: SocketRegenerationExp
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

The dental socket heals spontaneously

Experimental group

EXPERIMENTAL

Distinct bone graft regeneration strategies (PRGF, Autologous bone and DFDBA)

Procedure: dental socket regeneration

Interventions

dental socket regeneration PROCEDURE

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Prosthodontics

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: January 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 11, 2022

Record last verified: 2022-01