Chlorhexidine Intracanal Medicament in Periodontal Healing in Concomitant Endo Perio Lesion With Communication
Condition: Periodontal Pocket; Tooth,Non Vital
MeSH terms: Periodontal Pocket; Tooth, Nonvital
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      INTRODUCTION:

      Treatment decision-making and prognosis of endodontic-periodontal lesion is primarily
      dependent on the diagnosis of the specific endodontic or periodontal disease. Although the
      treatment of endodontic and periodontal lesions arouse a lot of confusions and speculations.
      Wherein, endodontic-periodontal combined lesion is a clinical dilemma because making a
      differential diagnosis and deciding a prognosis are difficult. Also, the success of such
      lesions depends on the elimination of both of these disease processes as the endodontic
      therapy results in healing of the endodontic component of involvement while the prognosis of
      tooth would finally depend on the healing of the periodontal structures.

      Interventional studies also reported negative influence on the periodontal healing in
      presence of infected root canal system, after providing periodontal treatment. However, in
      addition to this, the outcome of endodontic treatment may be affected if the root canal
      filling is placed while there is still a periodontal infection present that communicates with
      the root canal system since cross-seeding through the apical or lateral foramina is possible.
      Despite thorough cleaning and disinfection of the root canal system during endodontic
      treatment, bacteria from the periodontal lesion may re-invade the root canal system since
      root canal fillings do not seal canals completely.

      The elimination of microorganisms from infected root canal is a complicated task involving
      the use of various instrumentation techniques, irrigation regimens and intracanal
      medicaments. Gomes et al observed that 2% chlorhexidine (CHX) showed maximum zone of
      inhibition against porphyromonas gingivalis, enterococcus faecalis, actinomyces viscosus and
      candida albicans followed by a combination of calcium hydroxide and CHX, and least with
      calcium hydroxide alone. A clinical study carried out by zamany et al showed that 2% CHX
      solution used as a final irrigant, significantly decreased bacterial loads in root canal.
      Additional advantages of chlorhexidine are its retentive character in root canal dentin and
      its relatively low toxicity and its effect on periodontal healing has been well known. Based
      on these observations, it may be hypothesized that intracanal medicament may act as a
      controlled released drug which could be used as an adjunct to periodontal surgical therapy .

      Thus the present study was conducted to evaluate the effectiveness of chlorhexidine
      intracanal medicament along with periodontal surgical therapy on periodontal healing in
      concomitant endodontic and periodontic disease with communication.

      MATERIAL AND METHODS:

      This study was conducted in Department of Periodontics and Oral Implantology in collaboration
      with Department of Conservative Dentistry and Endodontics, Post Graduate Institute of dental
      sciences (PGIDS), Rohtak.

      The study protocol was carried out in accordance with the ethical standards outlined in the
      Helsinki declaration 1964, as revised in 2013.39. The protocol was approved by the
      Institutional Review Board, Pt. B. D. Sharma University of Health Sciences, Rohtak and the
      ethical approval (IEC/2014/115) was obtained from the ethical committee of PGIDS, Rohtak.

      STUDY POPULATION:

      This study was designed as a prospective randomized double blind controlled clinical trial.
      Patients were recruited from regular outpatient department of the periodontics, endodontics
      and oral diagnosis, PGIDS, Rohtak. A total of 250 patients were examined and out of them 47
      patients suffering from chronic periodontitis having combined endodontic periodontal lesion
      with communication and meeting the inclusion criteria were treated from May 2014 to September
      2015.

      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
           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. After confirming the
           eligibility, written and verbal informed consent was obtained from each patient.

      METHODOLOGY:

      Patients were randomly allocated to one of the two treatment groups according to a
      computer-generated randomization list. It was ensured that neither the investigator nor the
      patient was aware of the treatment protocol at the time of patient allocation. From each
      patient only one tooth was selected.

      Group 1 (n = 23 teeth/23 patients), endodontic treatment (ET) and full mouth scaling and root
      planing (SRP) were performed simultaneously. After 3 months of commencement of endodontic
      therapy, periodontal surgical treatment in the form of open flap debridement (OFD) was
      performed.

      Group 2 (n = 24 teeth/24 patients), endodontic treatment (ET) and full mouth scaling and root
      planing (SRP) were started simultaneously. After biomechanical preparation of root canal, CHX
      intracanal medicament was placed in root canal from pulp chamber to apex for 3 months
      (replacing every month). After 3 months, 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.

      Clinical Data Collection: Endodontic evaluation - Pulp sensibility testing was performed with
      a combination of heat test (heated gutta-percha), cold test (Endo-Frost, Coltene, Whaledent)
      and electric pulp test (Digitest D626D, Parkell electronics, New York). Teeth not responding
      to both thermal and electric test were considered non vital.

      Radiographic evaluation - Radiographs with paralleling cone technique were taken with
      standardized exposure parameters (70kvp, 3.5mAs, and 0.2 seconds) by single operator using
      dental x-ray machine .

      PERIODONTAL EXAMINATION

      CLINICAL PARAMETERS:

      Full mouth indices recorded at baseline Plaque index (Silness and Loe) (PI) Gingival index
      (Loe and Silness) (GI) Bleeding on probing (BOP) Probing pocket depth (PPD) Clinical
      attachment level (CAL) Site specific ( endo- perio involved tooth) indices Plaque index

        -  Gingival index

        -  Relative Probing pocket depth

        -  Relative clinical attachment loss

        -  Bleeding on probing

        -  Tooth mobility

        -  Relative gingival marginal level Clinical parameters were recorded at baseline, 3
           months, 6 months and 9 months. Each of the tooth was assessed at four sites
           (mesiobuccal, midbuccal, distobuccal, midlingual) for PI and GI and six sites
           (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for PPD,
           CAL, BOP during full mouth complete periodontal examination.

      PERIODONTAL NON SURGICAL PROCEDURE: All the patients enrolled for the study at the initial
      visits undergo non surgical periodontal treatment in the form of scaling and root planing
      (SRP) which was performed with ultrasonic scaler and hand instruments. SRP was completed in
      two to three sessions along with education and motivation to maintain the health of
      periodontium.

      CONVENTIONAL ENDODONTIC PROCEDURE: Simultaneously along with non surgical periodontal
      treatment, root canal treatment was performed by experienced endodontist using a standardized
      protocol. The standard procedures for all cases included local anaesthesia (2% lidocaine with
      1:80,000 epinephrine), rubber dam isolation, pulp extirpation and standard access cavity
      preparation. After flooding the pulp chamber with 3% sodium hypochlorite (NaOCl; Sainsbury
      plc, London, UK), canal negotiation & apical patency was achieved with #10 or #15K-files.
      Coronal flare was created with # 2 and #3 Gates-Glidden drills (Dentsply Maillefer, Tulsa,
      OK). Working length of each canal was established with Root-ZX apex locator (J Morita,
      Irwine, CA) and verified with radiographs. Canal instrumentation was performed with K files
      in a crown-down technique. The master apical file size was set at 3 sizes larger than the
      first binding file at working length. Instrumentation was carried out in conjunction with
      copious irrigation with 3% sodium hypochlorite using 27 gauge needles.

      In group 1, lentulospiral was used to fill all canals with calcium hydroxide and tooth was
      sealed with Intermediate Restorative Material and patients were scheduled for a second
      appointment to obdurate the root canals within 10 days. At the next appointment, calcium
      hydroxide paste was removed by using circumferential filing with Hedstrom-type files and
      copious irrigation with 3% sodium hypochlorite followed by 5.0 mL 17%
      ethylenediaminetetraacetic acid and a final rinse of 5.0 mL of 3% sodium hypochlorite. The
      canals were dried with sterile paper points and obturated by using lateral condensation
      technique with gutta-percha and zinc oxide sealer and permanent filling was placed in form of
      silver amalgam.

      In group 2, 2% CHX gel was placed and filled in the root canal space up to apex using 27
      gauge endodontic syringe after cleaning with 17% EDTA and saline and tooth was coronally
      sealed with glass inomer cement (Version 2, Shofu, Kyoto, Japan). This intracanal medicament
      was changed every 1 month for 6 months and after 6 months canals were obturated same as in
      group 1.

      PERIODONTAL SURGICAL PROCEDURE: 5% povidone iodine solution was used for extraoral antisepsis
      and intraoral antisepsis. After achieving local anaesthesia (2% lidocaine with 1:80,000
      epinephrine), buccal and lingual/palatal intracrevicular incision were made with BP blade
      number 15 and full thickness mucoperiosteal flaps were reflected including neighbouring
      teeth. Meticulous defect debridement and root planing was carried out using area specific
      gracey curettes and scalers to remove all the granulation tissue and deposits. After
      instrumentation, the root surface was washed with saline solution in attempt to remove any
      remaining detached fragments from the defect and surgical field. After debridement
      mucoperiosteal flaps was repositioned and secured by using 3-0 non absorbable black silk
      surgical suture. The surgical area was protected and covered with non eugenol periodontal
      dressing (coe pak, GC America Inc, USA) and post operative instructions were given.

      FOLLOW UP: All parameters were re-evaluated and recorded at baseline, 3 month, 6 month and 9
      month of follow up.

      STATISTICAL ANALYSES: Data were found to be non-normally distributed. Intragroup differences
      were analysed by Wilcoxan Signed Rank test. Intergroup comparison of measurements were
      analysed by Mann-Whitney U test..

      Partial correlation analysis was done to analyse the correlation between the type of
      treatment provided and clinical variables (at the 9 months of follow up) after controlling of
      potential confounders PI and age. All the variables that had shown a significant correlation
      were included in logistic regression analysis. Models were adjusted for the co-variates. The
      Hosmer-Lemeshow statistic was applied to verify the diagnosis of the goodness-of-fit
      regression model employed. All statistical analyses were two tailed with significance level
      at 0.05.
    

Intervention name(s): open flap debridement
Intervention type(s): Procedure
Intervention description(s): periodontal surgery in the form of open flap debridement was done in both the groups
Other intervention name(s): OFD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chlorhexidine; endodontic treatment