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

Primary Purpose

Alveolar Bone Loss

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

dental socket regeneration

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental group

Arm Description

The dental socket heals spontaneously

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

Outcomes

Primary Outcome Measures

Degree of mineralization

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

type of bone maturation

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05183386

First Posted

December 20, 2021

Last Updated

January 8, 2022

Sponsor

University of Salamanca

1. Study Identification

Unique Protocol Identification Number

NCT05183386

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2014 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Bone Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

The dental socket heals spontaneously

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

dental socket regeneration

Intervention Description

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

Primary Outcome Measure Information:

Title

Degree of mineralization

Description

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

Time Frame

2-12 months

Title

type of bone maturation

Description

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

Time Frame

2-12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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