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The Use of Chlorhexidine Gel Following EDTA Root Surface Etching as an Adjunctive to Open Flap Debridement in Treating Intra-Bony Defects

NCT05170932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-12-28

No results posted yet for this study

Summary

SUMMARY Chronic periodontitis is regarded as an inflammatory disease that affects the supporting tissues of teeth which could lead to bone destruction. According to the pattern of bone destruction, vertical infrabony defect could occur. Several biomaterials have been used to treat infrabony defects including bone grafts, membranes, anti-microbials, growth factor \& Enamel matrix proteins. CHX gel which has been widely used in the treatment of infra-bony defects.

Chemical treatment of root surfaces of teeth have been used as an adjunct with mechanical instrumentation. Among these chemical agents is EDTA which was found to be able to remove the smear layer and expose the collagen fibers on the root surface which would make the root surface biocompatible favoring fibroblast attachment and increase substantivity of CHX gel. However, studies have found that there was no clinical significance of EDTA with chlorhexidine gel .

Recent studies revealed that significant improvements could be obtained for deep intrabony defects after EDTA root surface etching and CHX gel application after non-surgical therapy compared to control non etched treated sites. This could be attributed to the associated prolonged and higher values of CHX levels for the CHX-EDTA-treated group. However, the main target of that work is to quantify levels of CHX during the early stages of healing to determine if such clinical improvement could be attributed to prolonged and increased CHX levels after EDTA root surface preconditioning.

The aim of this study was to evaluate clinically the use of Chlorhexidine gel following root surface EDTA after open flap debridement in treating Intra-bony defects and to study the effect of EDTA bone etching on Bone Morphogenetic Protein-2 (BMP-2) in gingival crevicular fluid.

Conditions

  • Periodontal Bone Loss

Interventions

PROCEDURE

CHX gel 2 % + 24% EDTA

The local drug delivery gel (24% of EDTA gel on root and bone surface and then application of 2% of chlorhexidine gel on root surface) were placed for group 2 in the periodontal pockets Filter paper were inserted into the orifice of the pocket for 1 minute. This was done in the day of surgery then after 3 days, 7 days, 14 days and 21 days after the local drug delivery to measure the gel release profile.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
32 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-31
Completion
2018-05-31

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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 NCT05170932 on ClinicalTrials.gov