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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05183386
Enrollment
30
Registered
2022-01-10
Start date
2014-01-01
Completion date
2020-01-01
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss

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.

Interventions

PROCEDUREdental socket regeneration

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

Sponsors

University of Salamanca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
type of bone maturation2-12 monthsHistological Assessment by Goldner Trichromic Stain of the grade of maturation in the regenerated bone inside the alveolar walls
Degree of mineralization2-12 monthsHistological Assessment by Von Kossa Stain of the degree of the mineralization in the regenerated bone inside the alveolar walls

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026