This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak
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 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|
- PPD [ Time Frame: 6 and half months ]
Probing pocket depth
- CAL [ Time Frame: 6 and half months ]
Clinical attachment loss
|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|
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.
- 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.
- Previously root canal filled tooth.
- Patients with aggressive periodontitis
- History of periodontal treatment within 6 months prior to study.
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:
Anti-Infective Agents, Local
ClinicalTrials.gov processed this record on May 30, 2017