Comparative evaluation of efficacy of three intracanal medicaments on post-operative pain- A randomized control trial

For many years pain of endodontic origin has been a chief concern to the patients and the clinicians(1). It may occur as a result of several factors, including chemical, mechanical or bacterial irritation to periapical tissues(2). In order to reduce pain, and regarding the recommendation of treating necrotic teeth, intra-canal medicaments can be used between sessions(3). The choice of which intracanal medicament to use rely on having an accurate diagnosis of the condition being treated(4).

Calcium hydroxide has been used in dentistry for almost a century(5). It is characterized by its initial bactericidal, bacteriostatic effect and its high ph. It has been suggested that calcium hydroxide has pain preventive characteristics due to antibacterial action or tissue altering effects(2). Its use in root canal treatment as an intracanal medicament has been associated with periradicular healing(5).

Chlorhexidine gluconate (CHX) is a broad-spectrum antimicrobial agent that has been advocated as an effective medication in endodontic therapy(6). Chlorhexidine is a cationic bisguanide used in apical periodontitis that seems to act by adsorbing into the cell wall of micro-organism and causing leakage of intracellular components. Its cationic structure provides a unique property named substantivity(7). At low concentration chlorhexidine has bacteriostatic effect and at high concentration it has bactericidal effect because of precipitation and /or coagulation of intracellular components(5).

Double antibiotic paste (DAP) is a mixture of metronidazole and ciprofloxacin, which is used as intracanal medication for disinfection of necrotic teeth. It has been reported to be effective at reducing bacterial counts in infected root canals(2). The use of DAP was suggested to overcome the discoloration problem associated with minocycline in triple antibiotic paste.

 Pre-operative and post-operative pain to be recorded by Heft Parker Visual Analogue scale(8).

 The aim of the current study is to compare and evaluate the efficacy of three intracanal medicaments on post-operative pain - a randomized control trial.

AIM

To evaluate and compare the efficacy of three intracanal medicaments on post-operative pain

OBJECTIVE

To evaluate and compare the efficacy of three intracanal medicaments on post-operative pain

SAMPLE SELECTION

Patients with necrosis and symptomatic apical periodontitis on mandibular first or second molars reporting to Department of Conservative Dentistry & Endodontics at Manav Rachna Dental College, Faridabad. Informed Consent will be taken.

SAMPLE SIZE- 96

The study shall evaluate the difference of means in experimental groups. Taking alpha and beta errors of 0.05 and 0.20, at least 24 patients are required to detect a 15% difference in the mean pain score of different groups, considering a standard deviation of 18 in mean pain score.

Power of study- 80%

STUDY DESIGN- Interventional study (Randomized Control Trial)

INCLUSION CRITERIA

•        Mandibular molar teeth diagnosed with necrosis and symptomatic apical periodontitis.

•        Teeth with mature apices.

•        Teeth with multiple root canals.

•        Non-use of anti-inflammatory and analgesics.

•        Healthy persons with age 18-65 years

•        The ‘faint, weak or mild’ pre-operative pain corresponding to ≤54 mm on HP-VAS will be taken

 EXCLUSION CRITERIA

•        Patients with any systemic disease.

•        Mobile teeth.

•        Pregnant or lactating women.

•        Patients with history of allergy to any of the components.

•        Teeth associated with fluctuant facial swelling

•        Teeth with previous RCT.

•        Teeth with root resorption.

•        Teeth with severe damage.

METHODOLOGY

                N= 96

(mandibular 1st or second molar, permanent teeth with mature apices)

Patients were asked to complete the Heft Parker VAS before local anesthesia

Pulp vitality tests performed, and teeth are anaesthetized using LA containing 2% lidocaine with 1:80000 epinephrine

Disinfection of surrounding areas will be done and tooth will be isolated with rubber dam

Access opening establish patency with 15k file.

Occlusion will be relieved and working length is determined with the help of electronic apex locator and periapical radiograph.

Root canals are prepared using Niti rotary files.

During instrumentation process, each canal is irrigated with 5 ml of 3% sodium hypochlorite and saline using 30-gauge needle placed 0.5 mm short of working length.

Patients will be randomly divided into 4 groups. Randomization to be done using online random generator on randomization.com

GROUPING

 GROUP A GROUP B          GROUP C       GROUP D

GROUP A   =         CALCIUM HYDROXIDE GROUP

GROUP B   =         DOUBLE ANTIBIOTIC PASTE

GROUP C   =         2% CHLORHEXIDINE GROUP

GROUP D   =         CONTROL GROUP

 GROUP A-Each canal will be irrigated with 3 ml of 17% EDTA for 1 minute and then 5 ml of 3% sodium hypochlorite for 2 minutes. Canals will be irrigated with 5 ml of saline, dried and medicated with calcium hydroxide paste plugged into the canals by using lentulospiral.

GROUP B- Each canal is irrigated with 3 ml of 17% EDTA for 1 minute and then 5 ml of 3% sodium hypochlorite for 2 minutes. Canals will be irrigated with 5 ml of saline, dried and medicated with double antibiotic paste plugged into the canals by using syringe

GROUP   C- Each canal is irrigated with 3 ml of 17% EDTA for 1 minute and then 5 ml of 3% sodium hypochlorite for 2 minutes.

Canals will be irrigated with 5 ml of saline, dried and filled with 2% chlorhexidine gluconate solution using syringe.

 GROUP D- No dressing. (Control group)

 In all respective groups, temporary dressing is given, and patient is recalled after 1week.

By using Heft Parker VAS post-operative pain will be evaluated at 6, 24, 48, 72 hours and consecutively for 4 more days

After 1 week, root canals are obturated using cold lateral condensation technique with gutta percha and AH plus sealer.

STATISTICAL ANALYSIS

The data will be statistically analysed using suitable statistical test such as ANOVA test or Kruskal- Wallis test.