Chlorhexidine-Metronidazole Combination as an Intracanal Medicament on Periodontal Healing

May 25, 2017 updated by: Postgraduate Institute of Dental Sciences Rohtak

Effects of Chlorhexidine-Metronidazole Combination as an Intracanal Medicament on Periodontal Healing in Concurrent Endodontic Periodontal Lesions With Communication: A Randomized Controlled Clinical Study

Considering the beneficiary properties of both Chlorhexidine (CHX) and Metronidazole (MTZ) such as property of substantivity and diffusion of these drugs on the external surfaces through the anatomical communication channels in between the root canals and periodontium, may be utilized as an alternative approach for the delivery of drug ( intracanal medicament) in the deep periodontal pockets in concurrent endodontic- periodontic lesion with communication lesions. Thus the aim of study is to conduct a prospective randomized controlled clinical trial to evaluate and compare the effects of CHX-MTZ combination with chlorhexidine alone as an intracanal medicament on periodontal healing in concurrent endodontic- periodontic lesion with communication.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

INTRODUCTION

The pulp tissue within the tooth and surrounding periodontium are interrelated to each other due to structural, functional and microbiological similarities. Cross infection of bacterial colonies take place in between these sites through dentinal tubules, apical foramen, lateral and accessory canals.Concurrent endodontic- periodontic lesions are those lesions where both endodontic and periodontal diseases occurring at same time in relation to single tooth.

Endodontic infection present in tooth is responsible for more bone loss, attachment loss and results in impaired healing of periodontium and vice versa.

Complete elimination of microorganisms from infected root canal is very challenging and complicated task. It has been reported that bacteria may survive within the root canal even after chemomechanical preparation, these remaining bacteria again multiply within the root canal. So, intracanal medicament is used as an adjunct to mechanical preparation in disinfection of root canal system.

Chlorhexidine (CHX) is widely used as an intracanal medicament because of its high antimicrobial action, against gram positive and gram negative bacteria.

Antibacterial substantivity of CHX is significantly higher than other medicaments. Various microbiological studies found the reduction in bacterial adherence, lager zones of microbial inhibition after application of CHX as an intracanal medicament. Raheja et al described that 2% CHX gel as an intracanal medicament provide substantive antibacterial activity for sufficiently long periods of time and helps in better healing of endodontic periodontal lesions without communication in their clinical study. Although, CHX is very effective as an intracanal medicament, but can't be used as an final irrigant due to it allergic, hypersensitive reaction, precipitation formation with sodium hypochlorite, EDTA, saline and ethanol and its inability to dissolve necrotic tissue.

In endodontic and periodontal treatment, antibiotics are valuable adjunctive for management of bacterial infections. Local application of antibiotics is considered more effective than systemic administration because of potential risk of adverse effects associated with systemic application.Metronidazole(MTZ) is nitroimidazole compound having broad antibacterial spectrum of bactericidal action mainly against anaerobic microorganisms. MTZ is given along with ciprofloxacin and minocycline as a combination in 3M antibiotic paste in the form of intracanal medicament. Kargul et al in a clinical study showed that there was no abscess formation and pathologic mobility when metronidazole is used as an intracanal medicament.Observations based on in vitro study showed that MTZ-CHX combination was better than calcium hydroxide as an intracanal medicament against E.faecalis.

Keeping in mind the above observations and considering the beneficiary properties of both CHX and MTZ such as property of substantivity and diffusion of these drugs on the external surfaces through the anatomical communication channels in between the root canals and periodontium, may be utilized as an alternative approach for the delivery of drug ( intracanal medicament) in the deep periodontal pockets in these lesions. Thus the aim of study is to conduct a prospective randomized controlled clinical trial to evaluate and compare the effects of CHX-MTZ combination with chlorhexidine alone as an intracanal medicament on periodontal healing in concurrent endodontic- periodontic lesion with communication.

MATERIAL AND METHOD

This study will be conducted in Department of Periodontics and Oral Implantology in collaboration with Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak. The study protocol is according to the ethical standards of Helinski declaration 1975 as revised in 2013.

STUDY POPULATION

Patients will be recruited from regular outpatient department of the periodontics, endodontics and oral medicine PGIDS, Rohtak. The study will be conducted as follows:

Interventional study: This randomized controlled clinical trial will include minimum 36 patients which will be further divided into two groups.

Test Group (n≈ 18)

Treatment involves endodontic treatment using intracanal medicament (chlorhexidine metronidazole combination) along with open flap debridement.

Positive Control Group (n≈ 18)

Treatment involves endodontic treatment using chlorhexidine alone as an intracanal medicament along with surgical periodontal therapy in form of open flap debridement.

METHODOLOGY

Patients will be randomly allocated to control and test groups. The study will be conducted as follows:

  1. Presurgical therapy: which will be including

    • Oral hygiene instructions and patient motivation
    • Full mouth supragingival and subgingival scaling and root planning with ultrasonic scaler (EMS Piezon 250, Switzerland), hand scaler and curettes (Hu-Friedy) will be completed in two sessions.
    • Root canal therapy will be initiated in both the groups.
    • In Test group- Metronidazole-chlorhexidine combination (metronidazole-15mg, chlorhexidine gluconate-0.5%w/w)as an intracanal medicament and in positive control group 2% chlorhexidine gel will be placed in root canals. In both groups, total duration for medicament placement will be of 4 weeks.
  2. Surgical therapy : After 2 weeks of intracanal medicament placement in both test group and in control group, periodontal surgical procedure in the form of open flap debridement will be performed in both groups.
  3. At the time of periodontal surgical procedure, intracanal medicament will be replaced with fresh one and will be remained in the root canals further for 2 weeks (medicament placed for total duration of 4 weeks), after that obturation will be done in both groups.

A probing stent will be fabricated for every patient irrespective of the group, relative to which attachment level, pocket probing depth will be measured.

CLINICAL PARAMETERS

  1. Full mouth indices to be recorded at baseline

    • Plaque index(PI)
    • Gingival index(GI)
    • Bleeding on probing(BOP)
    • Probing Pocket depth(PPD)
    • Clinical attachment loss(CAL)

  2. Site specific indices

    • Plaque index(PI)
    • Gingival index(GI)
    • Relative Probing Pocket depth(RPPD)
    • Relative Attachment Loss (RAL)
    • Bleeding on probing (BOP)
    • Tooth mobility
    • Relative Gingival Marginal Level (RGML)

Using UNC 15 periodontal probe at 6 sites (mesiobuccal, distobuccal, mesiolingual, distolingual, and median points at buccal and at lingual aspects) per tooth except 3 rd molars for PPD, BOP, GML and CAL while 4 surfaces (mesial, distal, median points at buccal and lingual aspect) will be measured for PI, GI.

Customized bite blocks and parallel angle technique will be used to obtain radiographs.

Clinical parameters will be recorded at baseline, 2 weeks of endodontic treatment and at 3 months, 6 months of periodontal surgery.

PERIODONTAL NON SURGICAL PROCEDURE

This involves supragingival and subgingival scaling and root planing to be performed with ultrasonic scaler, hand scaler and curette and will be completed in minimum two sessions along with patient education and motivation.

ENDODONTIC PROCEDURE

After achieving local anaesthesia, access opening will be made with the help of round bur. Then the root canal will be thoroughly debride followed by copious irrigation and subsequently prepared with the help of endo files. After preparation of the canal, chlorhexidine- metronidazole combination as an intracanal medicament will be placed in test group, chlorhexidine medicament in positive control group and access cavity will be sealed with suitable sealer and medicament left inside for the above mentioned time period. Obturation will be performed with gutta percha and zinc oxide eugenol based sealer.

PERIODONTAL SURGICAL PROCEDURE

After administration of local anaesthesia, buccal and lingual/palatal intracrevicular incision will be made and mucoperiosteal flaps will be reflected including at least one tooth ahead and another behind the tooth. Meticulous defect debridement and root planing will be carried out using area specific curettes and scalers to remove all the granulation tissue. After instrumentation, the root surfaces will be washed with saline solution in attempt to remove any remaining detached fragments from the defect and surgical field. After debridement mucoperiosteal flaps will be repositioned and secured by using 3-0 non absorbable black silk surgical suture. The surgical area will be protected and covered with periodontal dressing and post operative instructions will be given.

POST OPERATIVE CARE

  • Suitable antibiotics and analgesics will be prescribed for 5 days.
  • Periodontal dressing and sutures will be removed after 1 week.
  • Instructions will be given for gentle brushing with soft brush and reinstructed for proper oral hygiene postoperatively and will be examined weekly for up to 1 month after surgery and again at 3 and 6 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of age between 18-55 years with generalized chronic periodontitis will be enrolled, having at least one tooth with concurrent endodontic periodontal lesion with communication including following features:

    • a clinical and radiographic diagnosis of concurrent endodontic periodontal lesion
    • Wide base pocket, deep probing pocket depth
    • Non vital tooth on the basis of pulp sensibility tests along with periapical radiolucency
    • Radiographic alveolar bone (marginal bone) destruction with apical communication
  • Patients of generalized chronic periodontitis will be selected on the basis of Armitage classification of periodontal diseases and conditions [≥30% sites involved with clinical attachment level (CAL) 1-2mm (mild) or 3-4mm (moderate) or ≥5mm (severe)]
  • Patients should have more than 20 teeth in their oral cavity excluding third molars.

Exclusion Criteria:

  • Systemic illness known to affect the periodontium or outcome of periodontal therapy.
  • Patient taking medications such as corticosteroids, calcium channel blockers and anticoagulant therapy, which are known to interfere periodontal wound healing or patient on long term NSAID therapy or bisphosphonates.
  • Patients allergic to medication (chlorhexidine, local anaesthetic, antibiotics, NSAID).
  • Patients with acute symptoms.
  • Pregnant or lactating females.
  • Smokers (current and past) and tobacco chewers.
  • Grade 3 mobile teeth.
  • Unrestorable tooth.
  • Root resorption.
  • Fractured/perforated roots.
  • Developing permanent tooth.
  • Abutments.
  • Previously root canal filled tooth.
  • Patients with aggressive periodontitis
  • History of periodontal treatment within 6 months prior to study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Test Group
Endodontic treatment using chlorhexidine metronidazole combination as an intracanal medicament along with open flap debridement (RCT with CHX-MTZ,OFD).
Procedure: RCT with CHX-MTZ,OFD
Endodontic treatment using chlorhexidine metronidazole combination as an intracanal medicament along with open flap debridement .
ACTIVE_COMPARATOR: Positive Control Group :
Endodontic treatment using chlorhexidine as an intracanal medicament along with surgical periodontal therapy in form of open flap debridement(RCT with CHX,OFD).
Procedure: RCT with CHX,OFD
Endodontic treatment using chlorhexidine as an intracanal medicament along with surgical periodontal therapy in form of open flap debridement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PPD
Time Frame: 6 and half months
Probing pocket depth
6 and half months
CAL
Time Frame: 6 and half months
Clinical attachment loss
6 and half months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Postgraduate Institute of Dental Sciences Rohtak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • kirtika perio 2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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