Effect of Cryotherapy on Post-operative pain with different irritation systems during Root Canal Treatment. A prospective Randomized Clinical trial.
- Conditions
- Pulpitis,
- Registration Number
- CTRI/2020/11/029089
- Lead Sponsor
- Self Sponsored By Dr Anil Chandra
- Brief Summary
Post-operative pain following root canal treatment is an iatrogenic outcome that occurs despite the best of the protocols followed(1). Post-operative pain can occur due to inadvertent mechanical, chemical or microbiological injury to the peri radicular tissues. These untoward events lead to periradicular inflammation resulting in severe pain or endodontic flare ups(1,2).
Endodontic flare ups although rare, occur despite the best of the efforts because of the complex nature of root canal system where in the anticipation of cleaning the apical one third or maintaining the apical patency, debris gets pushed into the periradicular area causing inflammation and severe pain later on(2).
Various strategies have been used to counteract the post-operative pain following root canal treatment such as analgesics, corticosteroids, occlusal reduction etc(3–5). Newer irrigation devices that minimize the periapical extrusion of the irrigants and debris have been introduced such as apical negative pressure irrigation devices, ultrasonics and agitation devices that aim to clean the apical one third of the root canal and at the same time preventing the apical extrusion of the irrigants or debris and in turn preventing the post-operative pain or flare ups.
Endovac is one such apical negative pressure irrigation system which because of its three cannulas i.e. micro, macro cannula and master delivery tip is able to eliminate the debris from the apical one third of the root canal system and at the same time minimize the periapical extrusion of the debris(6). Irrigant delivery with negative pressure systems have advantage over the conventional positive pressure irrigation devices as evidence suggests that irrigant only travels to a distance of 1-2mm beyond the conventional needle tip(7).
Sonic irrigation devices have also been introduced which work on the principle of cavitation and acoustic streaming and at the same time activating and agitating the irrigant causing disruption of biofilms, smear layer and apical flow of the irrigant(8).
Cryotherapy is a long standing technique that has been employed since ages in sports related injuries and post-operative pain management(9). The mechanism of action is that cold basically subtracts heat from tissues and results in a decreased temperature. When the temperature decreases, vasoconstriction occurs and restricts oedema formation. Vasoconstriction also decreases cell metabolism, thereby reducing the oxygen demand of cells and limiting the production of free radicals in tissues. Cryotherapy also affects the conduction capacity of nerves and thereby inhibiting the effect of nociceptor stimulation(9,10).
**Review of Literature**
Gondim E et al. (2010) evaluated the postoperative level of pain after root canal therapy using either endodontic needle irrigation or a negative apical pressure device by performing a randomized clinical trial on patients undergoing root canal treatment. From their study they came to the conclusion that use of negative pressure irrigation system can significantly reduce the postoperative pain in comparison to conventional needle irrigation system.(11)
Keskin C et al. (2017) evaluated the effect of 2.5°C cold saline irrigation as final irrigant on postoperative pain after single-visit root canal treatment of teeth with vital pulps. There experimental groups included irrigation with cold saline and control group consisting of irrigation with normal saline at room temperature. The outcome of this investigation indicated that 2.5°C cold saline irrigation as final irrigant can result in a significant reduction in postoperative pain levels in comparison to the control group(12).
Vera J et al. (2018) conducted a prospective randomized multicenter clinical trial to assess the post-operative pain following controlled irrigation with negative pressure device in patients undergoing root canal treatment. A 210 patients requiring root canal treatment were randomly allocated to two group i.e. group 1: cold normal saline irrigation and group 2: normal saline at room temperature. Postoperative pain after 6, 24, and 72 hours (recorded in a VAS scale) and the need for analgesic medication intake between the 2 groups were assessed. Their results showed that cryotherapy significantly reduced the post-operative pain in comparison to control group where irrigation with normal saline at room temperature was done(13).
**1.****Hypothesis and Objectives:**
Recently studies have shown the efficacy of Intracanal cryotherapy in the postoperative pain management when irrigation was performed using apical negative pressure system(11).
No published literature till date has evaluated the effect of Intracanal cryotherapy using different irrigation devices and it will be very interesting to know whether any significant difference exits when cold normal saline is delivered by different irrigation devices.
The null hypotheses tested will be that there would be no difference among the experimental groups in terms of post-operative pain following irrigation with cold normal saline.
**2.****Aim & Objectives:**
To evaluate the effect of intracanal cryotherapy in the incidence of post-operative pain following irrigation with different irrigation systems i.e. apical negative pressure and sonic irrigation system.
**Materials & Method:**
**Study Setting:**
The present hospital based prospective single blind randomized controlled trials (RCT) will be conducted in the Department of Conservative Dentistry and Endodontics, King George’s Medical University Lucknow INDIA after getting ethical clearance from the Institutional ethics committee followed by clinical trial registration at CTRI INDIA. The study duration will be one year.
**Root Canal Procedure:** Root canal treatment to be performed in two visits. Informed consent to be taken from patients after explaining about the procedure. In the first appointment, Local anesthesia to be administered. Rubber dam isolation, Access cavity to be made using sterile endo access bur. Coronal third of the root canal to be flared using 25/08 Hyflex EDM (coltene whaledent) rotary instrument attached to X-mart Endomotor at 350rpm. Working length to be recorded with an apex locator using 10k and 15k file and confirmation to be done using digital radiograph. Cleaning and shaping of the canal to be done using Protaper universal files till F4. In between instrumentation, irrigation to be done using 5ml of 3% NaOCl (septodont) solution using 30 gauge Navi tip needle. Apical patency of the of the canal was maintained using 10k file 1mm beyond the registered working length. 17% EDTA to be delivered to 1 mm from the WL as a final irrigant and maintained intracanal for 1 minute. The root canals to be dried with sterile paper points.
**Study groups and Intervention:**In this study, there will be two treatments groups and one control group as given below;
**Group I (Negative Pressure Group)** : The tooth irrigated with 20 ml of cold (2.50 C) saline.
**Group II (Sonic Irrigation Group) :**The tooth irrigated with 20 ml of cold (2.50 C) saline with the help of 30 gauge Navi tip needle and then it agitated with a fiber tip mounted on Endoactivator . ENDOACTIVATOR® DENTSPLY MAILLEFER
**Group III (Conventional Needle i.e. Control Group):** The tooth irrigated with 20 ml of cold (2.50 C) saline with the help of 30 gauge Navi tip needle.
**Patients randomization and Allocation in Three Study group´s :**All the patients fulfilling inclusion criteria and given consent will be randomly allocated in one of the three groups for study using computer generated random number. Study will follow CONSORT 2010 guidelines. A total of 150 eligible patients and those will be given consent for this study, each study group´s participating in the study will have a list of 50 random numbers (between 1 to 150) assigned to that study group. All patients entering the facility will receive a consecutive number; an assistant will check the list to verify the group to which that patient would be assigned.
**Data collection:**VAS questionnaire will be given to the patients to record the intraoperative pain if any. Following the irrigation regimes in all the groups. The canals will be dried with sterile paper points, and calcium hydroxide will be placed intracanally with a Lentulo spiral 2 mm from the WL. A temporary filling will be placed, and occlusion will be checked.At this moment, a third questionnaire was given to the patient to record the presence, duration in days, level of postoperative pain, and analgesic intake. VAS pain score will be further divided into four groups as per standard criteria (No pain, Mild pain,
Moderate pain, Severe pain). Patients will be asked to record their pain experience if any at the interval of 6hrs, 24hrs and 3days using visual analog scale. All patients to be given visual analog scale (VAS), having rating from 0-10 with 0 demonstrating no pain and 10 demonstrating the most severe and unbearable pain to rate the pretreatment pain.
 
Recommended analgesic: Ibuprofen 600mg/8-12hrs.
Second appointment:
Patients will be recalled after 7 days.
Isolation of the tooth.
Temporary restoration to be removed and Intracanal Ca(OH)2 to be removed using the last instrument that was used to flare the working length using copious irrigation with 10ml of 3% NaOCl and final irrigation with 10ml of 17% EDTA.
Root canals to be dried using paper points and obturation to be completed.
**Inclusion and exclusion criteria:**
**Inclusion criteria:**
Healthy patients in the age group of 20-30 years.
Single rooted mandibular premolars.
Only teeth with the diagnosis of irreversible pulpitis or symptomatic apical periodontitis will be included.
Patients having intensity of pain falling in the range of 7-9 on VAS to be included.
**Exclusion criteria**:
Secondary infected root canal treated teeth.
Patients in long term medication for chronic pain.
Debilitating patients such as patients on immune suppressants,pregnant females etc.
Internal or external resorption.
Teeth with extreme curvature i.e. >30°
Roots having open apex or radiographically untraceable canals.
Teeth with periapical radiolucency more than 2mm.
**Sample size for primary outcomes:**
A study is planned to test whether reported pain incidences in root canal treatment patients for each of 2 treatment-group are significantly different from the control-group at the 0.05 significance level. The sample size of the control group is 43 and the sample sizes of the individual treatment groups are 43 and 43 (total 129) achieved 90.1% power of the test. The sample size and corresponding power are computed on basis of reported pain incidences in patients in control group (94.7%) and the treatment group 1 (66.6%) **[Vera J, et al, 2018]**and in treatment group2 (66.6% assumed).Finally, in this study we will target 50 patients in each of the three study groups (Total 150). Sample size was estimated using software Power analysis and sample size version -16 (PASS-16, NCSS, LLC, USA).
**Data Management and Statistical analysis:**Descriptive statistics of the continuous variable´s will be presented as mean± standard deviation / median (inter-quartile range) while categorical data in frequency (%). Distribution of patients characteristics, clinical variables and Visual analog scale (VAS) score of the patients will be compared in three study groups using One Way ANOVA test / Kruskal Wallis H test/ Chi-square test/ fisher exact test while change in VAS score and pain incidences over the multiple time points using Friedman test/ Cochran Q test as appropriate followed by multiple comparisons if applicable. A p value < 0.05 to be considered as statistically significant. Statistical package for social sciences, version-23 (SPSS-23, IBM, Chicago, USA) and MedCalc statistical software will be used for data analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 150
- Healthy patients in the age group of 20-30 years.
- Single rooted mandibular premolars.
- Only teeth with the diagnosis of irreversible pulpitis or symptomatic apical periodontitis will be included.
- Patients having intensity of pain falling in the range of 7-9 on VAS to be included.
- Secondary infected root canal treated teeth.
- Patients in long term medication for chronic pain.
- Debilitating patients such as patients on immune suppressants,pregnant females etc.
- Internal or external resorption.
- Teeth with extreme curvature i.e. >30° Roots having open apex or radiographically untraceable canals.
- Teeth with periapical radiolucency more than 2mm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All patients to be given visual analog scale (VAS), having rating from 0-10 with 0 demonstrating no pain and 10 demonstrating the most severe and unbearable pain to rate the pretreatment pain. Patients will be asked to record their pain experience if any at the interval of 6hrs, 24hrs and 3days using visual analog scale.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department Of Conservative Dentistry and Endodontics, King Georges Medical University Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Department Of Conservative Dentistry and Endodontics, King Georges Medical University Lucknow🇮🇳Lucknow, UTTAR PRADESH, IndiaDr Vijay Kumar ShakyaPrincipal investigator9452278876dr.vijay.shakya@gmail.com