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Impact of PTFE-d Barrier Intentionally Exposed to Bucal Environment in Guided Bone Regeneration to Ridge Preservation

NCT04329351 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-01

No results posted yet for this study

Summary

The aim of this clinical-laboratorial, paralel, randomized, prospective and controlled study was determine the impact of of PTFE-d barrier intentionally exposed to bucal environment in guided bone regeneration to ridge preservation, using microbiological, radiographic, patient-centered outcomes, molecular patter of bone-related markers and implant stabilization. Fourty individuals with tooth extraction indication and subsequent implant placement between upper pre-molars were recruited. Patients were randomly allocated in one of this groups, following tooth extraction: 1) GBR: sockets received GBR with d-PTFE membranes which was maintained intentionally exposed to bucal environment and removed after 28 days; and 2) Non-GBR: sockets did not receive additional therapy after extration. After 3 months, all patients received dental implants and temporary implant-supported prostheses. Patient-reported outcomes in terms of morbidity, swelling and interference with daily life were recorded at 3, 7, 14, 28, 35 and 42 days following dental extraction and in terms of esthetic outcomes after prosthesis instalation by using questionaries. Samples of biofilm at surface repair/barrier were obtained in both groups at 3 and 28 days after extraction (in the moment of barrier removal) to microbiological evaluation using Illumina HiSeq system. Computed tomography obtained imediatlly after extraction and before implant placement will be analised to evaluation of changes on ridge dimensions. After 3 months following extration, bone tissue biopsies will be harvested from the sites designed to receive dental implants to evaluation of imunoenzimatic pattern (DKK1, OPG, OC, OPN, TNF-α, SOST, RANKL, OSN e TRAP) and gene expression (TGF-β, BSP e COL-I) of bone-related markers using Luminex/Magpix and PCR Real-Time, respectivally. Afer imlpant placement, the implant stability quotient (ISQ) was determined. The results will be statistically compared after normality test, with the level of significance set at 5%.

Conditions

  • Ridge Preservation

Interventions

PROCEDURE

Guided Bone regeneration

Guided bone regeneration to ridge preservation

Sponsors & Collaborators

  • Fernanda Vieira Ribeiro

    lead OTHER

Principal Investigators

  • Zaffalon Casati Marcio · Paulista University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-03-13
Completion
2020-12-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329351 on ClinicalTrials.gov