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
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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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