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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

Primary Purpose

Periodontal Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CHX gel 2 % + 24% EDTA
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Bone Loss

Eligibility Criteria

32 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. Age from 32 to 60 years old.
  2. Females and males.
  3. Healthy adult patients.
  4. 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.

Exclusion criteria:

  1. Smokers.
  2. Breast feeding and pregnant females.
  3. Vulnerable group of patients (handicapped and prisoners).
  4. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    open flap + mechanical debridement

    open flap +CHX gel 2 % + 24% EDTA

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    bleeding on probing
    Williams graduated periodontal probe using bleeding index

    Secondary Outcome Measures

    Bone Morphogenetic Protein-2 (BMP-2)
    by Elissa kit release profile in gingival crevicular fluid.

    Full Information

    First Posted
    August 16, 2021
    Last Updated
    December 10, 2021
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05170932
    Brief Title
    The Use of Chlorhexidine Gel Following EDTA Root Surface Etching as an Adjunctive to Open Flap Debridement in Treating Intra-Bony Defects
    Official Title
    The Use of Chlorhexidine Gel Following EDTA Root Surface Etching as an Adjunctive to Open Flap Debridement in Treating Intra-Bony Defects.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    SUBJECTS AND METHODS A total of 20 patients were selected from the outpatient clinic of Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of Dentistry, Ain Shams University. The proposal reviewed by the research ethics committee, Faculty of Dentistry, Ain-shams University. Patients fulfilling the inclusion criteria were randomly divided into one of two groups using a randomizing program (Randomization.com): Group 1: This group included 10 patients with localized 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 sub-mechanical debridement then open flap debridement only. Group 2: This group included 10 patients with localized 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 sub-mechanical debridement 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. Inclusion criteria: Age from 32 to 60 years old. Females and males. Healthy adult patients. Selected patient with a single site of defect: Two walled defect 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. Exclusion criteria: 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. Measurements and indices: Clinical Assessment were done using Universal Dental Williams Michigan Probe. The following clinical parameters were measured in every patient before the surgery and after 3 months of the surgery: Initial therapy by full mouth supra and sub-gingival mechanical debridement using ultrasonic scaler and hand instruments have been done on all patients. The patients were given instructions for self-performed plaque control measures with soft dental brush and interdental cleaning using dental floss or interdental brush to achieve good oral hygiene. All groups were subjected to the previous procedure. All groups received open flap debridement after one month of scaling and root planning. Open flap debridement initiated by giving infiltration local anesthesia (Articaine Hydrochloride 4% and Epinephrine 1:100,000) to the affected area. Then a reverse bevel incision and full thickness flaps were elevated. This helped to gain access for deep scaling, root planning and removal of granulation tissues and tissue tags and irrigation into the pockets. Baseline samples from the gingival crevicular fluid were collected from all selected sites using filter paper inserted into the deepest part of each periodontal pocket and left in situ for 30 seconds for assessment of BMP-2 concentrations. In both groups, the area of selected pocket were completely dried using oil free air syringe, and then the site was isolated with cotton rolls to prevent contamination from saliva. 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 using a dedicated syringe until the gel flowed out from the gingival margin for 1 minute. 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. (Ahmed Y. Gamal and Jason M. Mailhot, 2007). The flaps were replaced as close as possible to their original position and sutured by polypropylene (4-0) suture with interrupted interproximal sutures to achieve as complete coverage of the inter-dental areas as possible. - Poste-operative care: All patients received amoxicillin antibiotic three times per day. Patients were also prescribed 0.12% chlorhexidine digluconate mouthwash (Hexitol antiseptic mouthwash, Arab Drug Company, Egypt) to be used twice per day for one week and were instructed to avoid brushing at the site of surgery for the first ten days. Sutures were removed after 1 week and then application of perio- pack for another 1 week and follow up after 3 months. 6) Biochemical assessment: i. EDTA and Chlorhexidine gel release profile: The collected samples were labeled and carried in a dark container until High Performance Liquid Chromatography (HPLC) evaluation. ii. Concentration of BMP-2: In both groups, assessment was done at baseline and one month after local drug delivery. BMP-2 concentrations were determined using a commercial human BMP-2 ELISA Kit. Measurements were performed according to the manufacturer's instructions. Measurement of BMP-2 in GCF by ELISA: GCF was extracted from the filter paper after addition of 100ul of PBS (pH 7) and centrifugation at 5000xg. The supernatant was used for measurement of the BMP-2. The kit was provided by Chongqing Biospes Co., Ltd, China (Catalog No.: BEK1014)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Bone Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    chlorhexidine gel, Biological drug
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    open flap + mechanical debridement
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    open flap +CHX gel 2 % + 24% EDTA
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    CHX gel 2 % + 24% EDTA
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    bleeding on probing
    Description
    Williams graduated periodontal probe using bleeding index
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Bone Morphogenetic Protein-2 (BMP-2)
    Description
    by Elissa kit release profile in gingival crevicular fluid.
    Time Frame
    3 months
    Other Pre-specified Outcome Measures:
    Title
    radiographic X ray
    Description
    long parallel technique
    Time Frame
    3 months
    Title
    Clinical attachment loss
    Description
    Williams graduated periodontal probe
    Time Frame
    3 months
    Title
    probing depth
    Description
    Williams graduated periodontal probe
    Time Frame
    3 months
    Title
    plaque
    Description
    plaque index using Williams graduated periodontal probe
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    32 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: 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. Exclusion criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17760546
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24844029
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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