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

NCT02627326 | Completed Phase 2 DMC

• 1 other identifier: perio1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Pocket; Tooth,Non Vital

Keywords

chlorhexidine; endodontic treatment

Outcome Measures

Primary Outcomes (3)

• probing pocket depth

  9 months

• clinical attachment level

  9 months

• bleeding on probing

  9 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Group 2 Chlorhexidine

ACTIVE COMPARATOR

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

Interventions

open flap debridement PROCEDURE

periodontal surgery in the form of open flap debridement was done in both the groups

Also known as: OFD

Group 1; Group 2 Chlorhexidine

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: December 10, 2015
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12