Chlorhexidine-Metronidazole Combination as an Intracanal Medicament on Periodontal Healing

NCT03169946 | Unknown DMC

• 1 other identifier: kirtika perio 2015
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periodontal and Endodontic Lesion

Outcome Measures

Primary Outcomes (2)

• PPD

  Probing pocket depth

  6 and half months

• CAL

  Clinical attachment loss

  6 and half months

Study Arms (2)

Test Group

ACTIVE COMPARATOR

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

Positive Control Group :

ACTIVE COMPARATOR

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

Interventions

RCT with CHX-MTZ,OFD PROCEDURE

Endodontic treatment using chlorhexidine metronidazole combination as an intracanal medicament along with open flap debridement .

Test Group

RCT with CHX,OFD PROCEDURE

Endodontic treatment using chlorhexidine as an intracanal medicament along with surgical periodontal therapy in form of open flap debridement.

Positive Control Group :

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

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

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: October 14, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share