Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain

NCT05033093 | Unknown

• 1 other identifier: 19/29.04.2021
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

After endodontic procedures, depending on the individual and many variables, postoperative pain can be occur within hours and continue for days following the treatment. It is thought that acute inflammation that develops due to chemical, mechanical or microbial injuries in the periapical tissue after endodontic treatment causes postoperative pain. Materials used for root canal obturation can reach periodontal tissues through the apical foramen, lateral canals or leakage and may affect the healing process in the periodontium. For this reason, knowing the properties of root canal obturation materials is important in terms of preventing postoperative pain. Calcium silicate-based root canal sealer are recommended to be used as they enhance healing after endodontic treatment by promoting differentiation of odontoblasts and the release of bioactive compounds. At the same time, it has been reported that it has less cytotoxic effect compared to the resin-based AH Plus, which is widely used for root canal). Silicone-based root canal sealers have good biological properties on human ligament periodontal fibroblasts. It has been reported that GuttaFlow Bioseal root canal sealer, which has been used in recent years, has less cytotoxic effect than GuttaFlow2, MTA Fillapex and AH Plus sealers. Ateş et al.(2019) evaluated that the effects of different root canal sealers on postoperative pain and reported that the use of iRoot SP or AH Plus did not significantly affect pain levels, but iRoot SP sealer required less analgesic intake than AH Plus sealer. Aslan et al. (2020) concluded in their study that calcium silicate and resin-based root canal sealers are similar in terms of postoperative pain and need for analgesic intake. Ferreira et al.(2020) compared the effects of AH Plus, Endofill and MTA Fillapex root canal sealers on postoperative pain and stated that all three root canal sealers cause similar pain levels. When reviewing the studies on postoperative pain, it is seen that mostly resin and calcium silicate based root canal sealers are evaluated. Studies on calcium silicate and silicone-based root canal sealers seem to focus more on cytotoxicity. However, no study has been found in the literature on the effect of GuttaFlow Bioseal sealer on postoperative pain, which has been popularity in recent years and has low cytotoxicity. Acoording to this information, it is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain.

Conditions

Postoperative Pain

Keywords

root canal; root canal sealer; postoperative pain

Outcome Measures

Primary Outcomes (1)

• VAS Scala

  PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.

  up to 7 days

Study Arms (3)

Ah Plus

ACTIVE COMPARATOR

All samples will be filled with Ah Plus root canal sealer and gutta percha

Drug: Root Canal Sealants

I Root SP

ACTIVE COMPARATOR

All samples will be filled with I Root SP root canal sealer and gutta percha

Drug: Root Canal Sealants

GuttaFlow Bioseal

ACTIVE COMPARATOR

All samples will be filled with GuttaFlow Bioseal canal sealer and gutta percha

Drug: Root Canal Sealants

Interventions

Root Canal Sealants DRUG

it is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain

Ah Plus; GuttaFlow Bioseal; I Root SP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy persons between the ages of 18 and 45 years
• Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis

You may not qualify if:

• Patients who are taken analgesic inflammatory drugs with in the last 12 hours
• Pregnancy or lactation
• Teeth with calcified canals
• Teeth with periodontal diseases
• Teeth with sensitive to percussion and palpation
• Teeth with root resorption
• Teeth with immature/open apex

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Related Publications (1)

• Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.

  PMID: 29571915 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Root Canal Filling Materials

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Hacer Şahin Aydınyurt, PhdD

CONTACT

905304589710; hacersahin@gmail.com

Murat Tunca, PhD

CONTACT

90530458910; dtmurattunca@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist. Prof.

Model Details: After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer ; G1: AH Plus G2: iRoot SP G3: GuttaFlow Bioseal to be used in the obturation process (n: 28).

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: September 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share