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

NCT05170932 | Completed

• 1 other identifier: 2731
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• bleeding on probing

  Williams graduated periodontal probe using bleeding index

  3 months

Secondary Outcomes (1)

• Bone Morphogenetic Protein-2 (BMP-2)

  3 months

Other Outcomes (4)

• radiographic X ray

  3 months

• Clinical attachment loss

  3 months

• probing depth

  3 months

Study Arms (2)

open flap + mechanical debridement

NO INTERVENTION

This group included 10 patients with periodontitis stage 2 or 3, grade A infra-bony defect sites (Caton, 2018) that had undergone proper curettage ensuring complete removal of all granulation tissue present within the defect by scaling and root planning then open flap debridement only.

open flap +CHX gel 2 % + 24% EDTA

EXPERIMENTAL

This group included 10 patients with periodontitis stage 2 or 3, grade A infra-bony defect sites (Caton, 2018) that had undergone proper curettage ensuring complete removal of all granulation tissue present within the defect by scaling and root planning then open flap debridement before treating root and bony walls of the pocket surfaces by application of 24% EDTA etching and washing with saline, then application of 2% chlorhexidine gel on root surface.

Procedure: CHX gel 2 % + 24% EDTA

Interventions

CHX gel 2 % + 24% EDTA PROCEDURE

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.

open flap +CHX gel 2 % + 24% EDTA

Eligibility Criteria

• Age: 32 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 32 to 60 years old.
• Females and males.
• Healthy adult patients.
• Selected patient with a single site of defect in single tooth:
• Two walled or three walled infra-bony defect. The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.
• Pocket depth of more than or equal to 5 mm. Clinical attachment loss equal or more than 3mm.

You may not qualify if:

• Smokers.
• Breast feeding and pregnant females.
• Vulnerable group of patients (handicapped and prisoners).
• Patients who have received any periodontal therapy or antibiotics in the last 6 months.
• The study protocol explained in details to all patients. Then a signed informed consent obtained from the patients. The data obtained from patients as well as the results of the follow up will be kept confidential.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (2)

• Gamal AY, Mailhot JM. Effects of EDTA gel preconditioning of periodontally affected human root surfaces on chlorhexidine substantivity - an SEM study. J Periodontol. 2007 Sep;78(9):1759-66. doi: 10.1902/jop.2007.070124.

  PMID: 17760546 BACKGROUND

• Gamal AY, Aziz M, Salama MH, Iacono VJ. Gingival crevicular fluid bone morphogenetic protein-2 release profile following the use of modified perforated membrane barriers in localized intrabony defects: a randomized clinical trial. J Int Acad Periodontol. 2014 Apr;16(2):55-63.

  PMID: 24844029 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Edetic Acid

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: chlorhexidine gel, Biological drug

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: December 28, 2021
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2018
• Last Updated: December 28, 2021

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share