An interventional study of AH plus sealer and Bioceramic sealer in Asymptomatic Apical Periodontitis, sponsored by Primary Health Care Corporation, Qatar. Recruiting at 1 site in Qatar. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Primary Health Care Corporation, Qatar · Not applicable, Interventional, and Treatment
This study aims to compare the effect of bio ceramic sealer and resin-based sealer on the intensity and occurrence of post operative pain in single rooted teeth with asymptomatic apical periodontitis.
Root canal sealers are essential for the success of endodontic treatment. Their physical properties, biocompatibility, and interactions with peri-apical tissues directly affect postoperative pain and healing. Endodontic sealers activate trigeminal nociceptors, leading to the release of CGRP (calcitonin gene-related peptide), which causes pain and a neurogenic inflammatory response. Resin-based sealers are widely used in endodontics due to their superior physicochemical properties. However, they have limitations, including the need for a completely dry canal due to their marked hydrophobicity and their initial cytotoxic activity, which cannot be entirely controlled.
Bio-ceramic sealers represent a new generation of endodontic sealers that are favored by many dental professionals due to their small particle size (less than 2 micrometers), non-toxicity, high tissue compatibility, high hydrophilicity, and minimal dimensional changes. Retrospective studies have shown varying outcomes related to postoperative pain after root canal treatment using resin-based or bio-ceramic sealers.
Aim: This study aims to compare the occurrence and intensity of postoperative pain and analgesic intake after root canal treatment using two different types of root canal sealers.
Methods/Design: This study is a binary outcome randomized trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines for randomized trials of non-pharmacologic treatment. The study sample will consist of adult patients with a permanent single-rooted tooth diagnosed with asymptomatic apical periodontitis. Participants will be randomly allocated to be treated in the Endodontic clinic of PHCC Qatar with either resin-based sealers (control group) or bio-ceramic sealers (experimental group) to compare postoperative pain after root canal treatment.
Patients will be observed for occurrence of pain or any other complications at 24 hours, 48 hours, and 7 days post-treatment. Postoperative pain will be assessed using a visual analog scale (VAS) at 24 hours, 48 hours, and one week post-treatment.
Differences in the incidence of postoperative pain and the need for an analgesic will be analyzed using the chi-square test. Differences in pain intensity after treatment will be analyzed using the ordinal (linear) chi-square test.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Primary Health Care Corporation, Qatar is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The control group will be treated by using Resin based sealer during obturation which will be selected at random.
Combination Product: AH plus sealer
The comparator group will receive Bioceramic sealer during obturation as intervention which will be selected at random.
Combination Product: Bioceramic sealer
Root canal sealer will be placed inside the root canals during obturation procedure to seal dentine wall and reinforce the remaining tooth tissue.It will be selected randomly to the study samples.
Root canal sealer will be placed inside the root canals during obturation procedure to seal dentine wall and reinforce the remaining tooth tissue.It will be selected randomly to the study samples.
post operative pain questionnaire
The participants of the study groups will be given a questionnaire to record whether they experienced pain following the root canal treatment after applying each type of the study sealers or no, during the Time frame.
Time frame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
Intensity of postoperative pain
The patient will be asked to measure Intensity of their postoperative pain using a Visual Analog Scale. It consist of a straight line, usually 10 centimeters in length, with end point defining the extremes of pain. One end of the line represents no pain(usually marked as 0), while the other end represents' worst imaginable pain' (usually marked as 10) participant mark a point on the line that corresponds to their perceived pain intensity. The distance from the 'no pain' end to the mark is then measured and used to quantify the pain level during Time frame.
Time frame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
Analgesic
Analgesic intake recorded, The participants of the study will be asked to record any analgesic taken and the number of the tables during the Time frame.
Time frame: assessed at 24 hours, 48 hours, and 7 days post-treatment.
Plan to share: No — A password protected computer system is used to assure secure data storage.Only encrypted systems are used for storing research data on laptops. A locked file cabinet is used to store research related paper forms.Access to study data is limited to only a few members of the study team.Plans are set to destroy all research generated data after 3 years according to PHCC regulations.The study report / publication will show only aggregate results with no identifiers. Only deidentified study data is stored. A code number is used instead of the participant's real name on study data and blood/tissue samples.
Started Oct 2024 (actual). Primary completion is estimated for Oct 2025, 11 months after the start.
Of 171 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 11 months is close to that.
Counting every sponsor, half of 172 studies reached it within 12 months; a quarter within 6 and three quarters within 19.
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Primary Health Care Corporation, Qatar