To Compare post operative pain after single sitting root canal treatment using two different material:A randomized controlled Trial

Not yet recruiting

• Conditions: Healthy patients

• Registration Number: CTRI/2023/07/055672
• Lead Sponsor: Ashish Mandwe

Brief Summary

The incidence of postoperative pain after non-surgical root canal treatment is reported to be

in the range of 0 to 48%1,2. Several factors affecting postoperative pain have been

investigated, including working length determination,apical patency, various

Instrumentation or irrigation protocols, number of visits intracanal medicaments root canal filling techniques   and occlusion reduction

There were no differences in postoperative sensitivity in studies compared post-obturation pain using the same root canal

filling techniques but with different sealers in a single visit endodontic treatment.

Tricalcium silicate-based hydraulic cements are gaining popularity in non-surgical root

canal treatment. Even though long-term clinical trials are lacking, silicate-based hydraulic

cements have shown to be less cytotoxic compared to resin-based sealer in both ex vivo and

animal models.Premixed calcium silicate-based sealer has excellent physicochemical and

biological properties, both with in vitro and in vivo animal studies, compared with

conventional sealers .Root canal filling with calcium silicate-based sealer and a single

gutta percha cone using a sealer-based filling technique (SBT) is now widely accepted,

with a 90.9%reported success rate in a retrospective clinical study at three years of observation

.Graunaite et al. (2018) found no statistically significant difference in postoperative pain

when previously treated teeth were obturated with the different sealers using a warm

vertical compaction technique. The postoperative pain was generally mild and did not last

past 72 hours.11 Another trial by Ates et al. (2019) measuring postoperative pain after

obturation using a carrier-based system with either AH plus R or iRoot SPR also showed

that postoperative pain levels were not affected by the type of sealer used, although patients

who received iRoot SPR required less analgesics postoperatively.

Christine Men Martins et al (2019) meta-analysed and found that Rotary instrumentation

generated more events of pain confirming the hypothesis that rotary motion causes more

postoperative pain after endodontic treatment. In addition, more patients presented with

severe pain after 48 h under rotary motion compared to reciprocating motion. Therefore,

Additional randomized clinical studies are required on this subject.

A large number of studies investigated the effect of various instrumentation systems on

postoperative pain. According to a recent meta-analysis by Sun et al.33 and

CaviedesBucheli et al.34, the use of multiple-file rotary systems showed a lower incidence

of postoperative pain than the single-file reciprocating systems. On the contrary,

Neelakantan& Sharma 13 and Shokraneh27 reported higher pain intensity with multiple-file

rotary systems when compared to single-file reciprocating systems But literature lacking

,with the introduction newer generations single rotary file like One shape, and its impact

on post operative pain.Also, literature search, shows few clinical studies compared effect of different sealer on

post obturation pain using Bio ceramic sealer and conventional resin-based sealer using

single sitting root canal treatmentafter using use of single file rotary system in non-vital

teeth.Furthermore, most of cases analysed on meta-analysis by Christine Men Martinset al

(2019) were on vital pulp teeth, which were considered to have less extrusion of

microorganisms into the periapex since root canal was not massively infected. It is reported

in the literature that an asymptomatic necrotic pulp with a periapical lesion is the most

likely predisposing clinical condition for the occurrence of postoperative pain.15It is also

observed that nonvital pulp teeth presented with more pain at 6 h and continued till 48 h

irrespective of file system and motion used.

So, in this in vivo study we will compare BioCeramic sealer and AH Plus sealer on post-

obturation pain in non- vital asymptomatic and symptomatic teeth which have undergone



root canal treatment at 6-, 12,24-,48- and 72-hour interval short term follow up and 7 to 10

days midterm follow-up.

There is need to verify weather after using newer bio ceramic sealers, will there be any



difference in post operative pain incidence and healing outcomes in non-vital teeth.



Primary objective is to assess incidences of post-obturation pain following single sitting

root canal treatment using BioCeramic sealer and resin-based sealer in nonvital teeth. And subsequent follow up for 2years to check healing outcomes using clinical and

radiographic interpretation.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-08
• Last Update Posted: 2023-07-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Healthy adults (Male and female) aged between 21- 45 years History of taking analgesic, not with in 72 hrs.
• Permanent mandibular first molars with fully formed apex undergoing endodontic treatment with infected root canals or having radiographic evidence of apical periodontitis in nonvital teeth Straight to curved canal with Canal curvature up to 20 degree(Schneider method) Permanent mandibular first molars with necrotic pulp with/without periapical lesion as per OstrovikPAI score 1,2,3.30 Main inclusion criteria were pulpal necrosis confirmed by negative response to hot and cold test with/without periapical lesion as per OstrovikPAI score 1,2,3.30 Presence of enough coronal tooth structure for rubber dam isolation.

Exclusion Criteria

• Teeth with previous root canal treatment and restorations.
• Teeth with cracks or fractures Patient taking analgesic with in 72 hours of period.
• Unrestorable teeth Teeth with incomplete root formation Calcified canals Internal resorption in canal or normal pulpof patient being referred for intentional endodontic therapy for prosthetic reasons to undergo a single visit root canal treatment.
• Teeth indicated for retreatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare incidence of post-obturation pain following single sitting root	To assess and compare incidence of post-obturation pain following single sitting root | Canal Treatment using Bioceramic and Epoxy resin-based sealer in nonvital teeth.
Canal Treatment using Bioceramic and Epoxy resin-based sealer in nonvital teeth.	To assess and compare incidence of post-obturation pain following single sitting root | Canal Treatment using Bioceramic and Epoxy resin-based sealer in nonvital teeth.

Secondary Outcome Measures

Name	Time	Method
Follow up for 2 years to check healing outcome on basis of clinical and radiographic	2 years

Trial Locations

Locations (1)

NAIR HOSPITAL DENTAL COLLEGE; 🇮🇳 Mumbai, MAHARASHTRA, India

NAIR HOSPITAL DENTAL COLLEGE

🇮🇳Mumbai, MAHARASHTRA, India

Dr Ashish Mandwe

Principal investigator

9220524842

drmandwe@gmail.com