OBJECTIVES
To evaluate and compare the efficiency of
antimicrobial peptide GH12 and chlorhexidine as final root canal irrigants in
a) microbial load reduction
b) postoperative pain assessment.
HYPOTHESIS
There is no difference in microbial load
reduction and postoperative pain (if any) between GH 12 and chlorhexidine when
used as final root canal irrigants.
MATERIAL AND METHODS RESEARCH DESIGN
The proposed study will adopt a two-arm
parallel, double-blinded, randomized controlled trial.
STUDY SETTING
Patients attending the outpatient
department of Conservative Dentistry and Endodontics, SCB Dental College and
Hospital, Cuttack, Odisha, will be recruited into the study based on the
inclusion and exclusion criteria.
ETHICAL CLEARANCE was obtained from the
Institutional Ethical Committee.
INFORMED CONSENT will be obtained from
every participant after explaining the study criteria.
PROTOCOL TO BE ADOPTED FOR THE PROPOSED
STUDY
Sample size calculation:
Calculations to determine the sample size
were performed using G* power software. The calculations were based on an
assumed effect size of 0.9821, an alpha level of 0.05, and the desired power of
80%. The estimated sample size was 36. Considering a 10% loss of follow-up, 40
subjects (20 in each group) will be included in the study.
Statistical tests:
The collected data will be subjected to
statistical analysis using the Statistical Package for the Social Sciences
(SPSS) version 29.0 (IBM Corporation, USA). The normality of the data will be
checked using the Shapiro-Wilk test. Descriptive analyses will be done. For
intragroup comparisons, a paired sample t-test or Wilcoxon signed-rank test
will be used. For intergroup comparisons, an independent sample t-test or
Mann-Whitney U test will be used. P-value less than 0.05 will be included in
the study
TREATMENT PROCEDURE:
The patient will be randomly divided (using
randomiser software) into two groups (I &II) (n=20) according to the final
irrigation solution to be used.
All endodontic procedures will be performed
by one endodontist under strict aseptic conditions with local anaesthesia (2%
lidocaine & epinephrine at 1:80,000) and rubber dam isolation.
The access cavity will be prepared, and
straight-line access to the canal will be obtained.
After accessing the pulp chamber, the root
canal will be explored with a size 10K file
Working length will be determined with the
help of an electronic apex locator and confirmed radiographically.
Patency will be verified with size 20, 0.02
taper K-file to ensure that the sterile paper-points will reach the
sampling site.
SAMPLE 1 (S1)
3 sterile absorbent paper points (ISO #20/2%) inserted along the entire length of
the root canal, remaining in position for 60 seconds
If the root canal was dry, it was moistened with sterile saline solution
to ensure a viable specimen.
After sampling, points were immediately placed
into a Cryotube containing Phosphate Buffer solution and stored
at -20 °C &
subsequently sent for RT- PCR analysis.
Root canal instrumentation will be
performed using rotary instruments & the canal will be irrigated with 2ml
of 3% NaOCl solution using 30G side-vented needle after each instrumentation
and rinsed using 5ml of sterile saline solution.
For smear layer removal, 2 mL of 17%
EDTA will be added inside the root canal and activated for 30 s. The root
canal will be refilled with 17% EDTA and activated for another 30 s.
Patency will be verified with a size 20,
0.02 taper K-file to ensure that the sterile points will reach the sampling
site.
SAMPLE 2 (S2):
S2 will be
collected using sterile absorbent paper points (size 20) inserted along the
entire length of the root canal, remaining in position for 60 seconds.
If the root
canals are dry, they will be moistened with sterile saline solution to ensure a
viable specimen.
Upon withdrawal
from the root canal, points will be immediately placed into a Cryotube
containing Buffer solution and stored at -20 °C & will be sent for RT PCR.
In group I, 5ml of GH12 (3.2mg/100ml) will
be used as the final irrigant.
In group II, 5ml of 2% CHX will be used as
the final irrigant.
SAMPLE 3 (S3):
S3 will be
collected using the same methods as S1 after final irrigation in both groups.
Upon withdrawal
from the root canal, the paper point will be immediately placed in a Cryotube
containing Buffer solution and stored at -20 °C & will be sent for RT-PCR
analysis.
The root canals will be dried with
absorbent paper points and the access cavity will be sealed with 2mm of
temporary material and Glass Ionomer Cement. During the second visit, after 7
days, the canal will be obturated with gutta-percha points and resin-based
sealer. The teeth will be restored with composite resin. Postoperative
intraoral periapical radiographs will be taken immediately after obturation.
POST-ENDODONTIC PAIN ASSESSMENT
The degree of post-endodontic pain will be
measured using an 11-level numeric rating scale (NRS) at 24, 48, and 72 h and
5th day. Number 0 represents no pain and number 10 represents the most pain. |