Chlorhexidine-Metronidazole Combination as an Intracanal Medicament on Periodontal Healing


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This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Postgraduate Institute of Dental Sciences Rohtak

ClinicalTrials.gov Identifier:

NCT03169946

First received: May 24, 2017

Last updated: May 25, 2017

Last verified: May 2017

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.

Periodontal and Endodontic Lesion Procedure: RCT with CHX-MTZ,OFD
Procedure: RCT with CHX,OFD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effects of Chlorhexidine-Metronidazole Combination as an Intracanal Medicament on Periodontal Healing in Concurrent Endodontic Periodontal Lesions With Communication: A Randomized Controlled Clinical Study

Primary Outcome Measures:

  • PPD [ Time Frame: 6 and half months ]

    Probing pocket depth

  • CAL [ Time Frame: 6 and half months ]

    Clinical attachment loss

Estimated Enrollment: 36
Actual Study Start Date: October 14, 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT03169946     History of Changes
Other Study ID Numbers: kirtika perio 2015
Study First Received: May 24, 2017
Last Updated: May 25, 2017
Individual Participant Data  
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:

Chlorhexidine
Chlorhexidine gluconate
Metronidazole
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 30, 2017