Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02627326 |
| Other study ID # |
perio1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
December 6, 2015 |
| Last updated |
December 8, 2015 |
| Start date |
May 2014 |
| Est. completion date |
October 2015 |
Study information
| Verified date |
December 2015 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
India: Drugs Controller General of India |
| Study type |
Interventional
|
Clinical Trial 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.
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.
