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Chlorhexidine Intracanal Medicament in Periodontal Healing in Concomitant Endo Perio Lesion With Communication

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ClinicalTrials.gov Identifier: NCT02627326
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

Brief Summary:
The aim of this prospective randomized controlled clinical trial is to evaluate the effectiveness of chlorhexidine intracanal medicament along with periodontal treatment in concomitant endodontic periodontal lesions with communication in terms of periodontal healing. Forty-seven patients were randomly divided into: group 1: conventional endodontic treatment with open flap debridement (OFD after 3 month of endodontic treatment) were performed, in group 2: endodontic treatment with 2% chlorhexidine gel (CHX) as an intracanal medicament placed in root canals and after 3 month OFD were performed. Primary outcome variables included probing pocket depth, clinical attachment level and bleeding on probing.

Condition or disease Intervention/treatment Phase
Periodontal Pocket Tooth,Non Vital Procedure: open flap debridement Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Effectiveness of Chlorhexidine Intracanal Medicament on Periodontal Healing in Concomitant Endodontic and Periodontal Disease With Communication : A Randomized Controlled Clinical Trial
Study Start Date : May 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Active Comparator: Group 1
Interventions done in 30 patients and included conventional endodontic treatment (ET) and periodontal surgery . After 3 months of completion of endodontic therapy without using 2%chlorhexidine gluconate gel intracanal medicament , periodontal surgery in the form of open flap debridement (OFD) was performed.
Procedure: open flap debridement
periodontal surgery in the form of open flap debridement was done in both the groups
Other Name: OFD

Active Comparator: Group 2 Chlorhexidine
Interventions done in 30 patients and included intracanal medicament . After biomechanical preparation of root canal, 2%Chlorhexidine gluconate gel as an intracanal medicament was placed in root canal from pulp chamber to apex for 3 months (replacing every month). After 3 months,periodontal surgery in the form of open flap debridement (OFD) was performed in the respective tooth and medicament was changed and placed further for 3 months (replacing every month). Obturation was done after 3 months of OFD.
Procedure: open flap debridement
periodontal surgery in the form of open flap debridement was done in both the groups
Other Name: OFD




Primary Outcome Measures :
  1. probing pocket depth [ Time Frame: 9 months ]
  2. clinical attachment level [ Time Frame: 9 months ]
  3. bleeding on probing [ Time Frame: 9 months ]


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

Inclusion Criteria:

  • Patients of age between 18-55 years with generalized chronic periodontitis and having at least one tooth with concomitant endodontic periodontal lesion with communication including following features:

    • a clinical and radiographic diagnosis of concomitant endodontic periodontal lesion
    • Wide base pocket, deep probing pocket depth
    • Non vital tooth with periapical radiolucency
    • Radiographic alveolar bone (marginal bone) destruction with apical communication Criteria for generalized chronic periodontitis [≥30% sites involved with clinical attachment loss (CAL) 1-2mm (mild) or 3-4mm (moderate) or ≥5mm (severe)]40 Patient should have more than 20 teeth

Exclusion Criteria:Systemic illness known to affect the periodontium or outcome of periodontal therapy.

  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy or bisphosphonates.
  • Patients allergic to medication (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.
  • Patients with aggressive periodontitis
  • History of periodontal treatment within 6 months prior to study.
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Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT02627326    
Other Study ID Numbers: perio1
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Keywords provided by Postgraduate Institute of Dental Sciences Rohtak:
chlorhexidine
endodontic treatment
Additional relevant MeSH terms:
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Periodontal Pocket
Tooth, Nonvital
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Pulp Diseases
Tooth Diseases