Effects of TheraCal PT, Biodentin, and MTA on Postoperative Pain After Full Pulpotomy in Permanent Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
In this study, the researchers will evaluate the effect of three highly biocompatible materials-TheraCal PT (ThPT), Biodentin, and MTA-on postoperative pain in permanent teeth affected by deep caries and symptomatic irreversible pulpitis. Participants: The study will include 51 participants aged between 18 and 45 years who are systemically healthy. Methodology: Pulpotomy Procedure: Pulpotomy will be performed on the lower first molar tooth of each participant. The teeth will be randomly divided into three groups, with 17 participants in each group. Coronal pulp tissue will be removed using a high-speed sterile diamond bur. Hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl, and this procedure may be repeated up to three times (totaling 6 minutes) if necessary. Use of Biocompatible Materials: After achieving hemostasis, one of the three biocompatible materials (TheraCal PT, Biodentin, or MTA) will be applied to the canal access. Participants will be prescribed NSAIDs. Pain Assessment: Preoperative Assessment : The pain intensity of participants will be recorded before treatment. Postoperative Assessment : Participants will report their pain intensity at the 6th, 24th, 48th, and 72nd hours and on the 7th day using the Visual Analogue Scale (VAS). Participants will return with their VAS charts for evaluation at the end of one week. Comparative Analysis: The primary outcome will be a comparative evaluation of postoperative pain intensity values among the three different materials used in pulpotomy treatment. This study aims to provide valuable information on the effectiveness of various biocompatible materials in postoperative pain management and to contribute to improving clinical decision-making processes in endodontic treatments.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• Age range should be between 18 and 45,
• Systemic disease should be absent,
• Apical periodontitis findings may or may not be present,
• Irreversible pulpitis symptoms should be present,
• The apex of the tooth should be closed,
• Pulp sensitivity tests (cold test and electric pulp test) should respond positively,
• Periodontal pocket depth and mobility should be within normal limits,
• Rubber dam isolation should be provided for the tooth to be treated,
• Restorative treatment of the tooth should be performed,
⁃ The patient's mouth opening should be sufficient.
Locations
Other Locations
Turkey
Faculty of Dentistry, Sivas Cumhuriyet University
RECRUITING
Sivas
Sivas Republic University Faculty of Dentistry
NOT_YET_RECRUITING
Sivas
Contact Information
Primary
Fatoş Albayrak assistant professor
fatosdt3248@outlook.com
+905532030079
Backup
ESRA Kazan kazan
dtesrakazan@gmail.com
+905349551076
Time Frame
Start Date:2024-12-12
Estimated Completion Date:2025-11-01
Participants
Target number of participants:51
Treatments
Active_comparator: ProRoot MTA Application Procedure
The coronal pulp tissue of the tooth will be removed using a high-speed sterile diamond bur. Then, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this procedure may be repeated up to 3 times (totaling 6 minutes) if necessary. After confirming bleeding control, ProRoot MTA material will be placed at the canal openings. Following a waiting period of 15 minutes, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as the base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.
After the coronal pulp tissue of the tooth is removed using a high-speed sterile diamond bur, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this may be repeated up to 3 times (for a total of 6 minutes) if necessary. Once bleeding control is established, Biodentin material will be placed at the canal openings. After a waiting period of 12 minutes according to the manufacturer's instructions, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as a base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.
After the coronal pulp tissue of the tooth is removed using a high-speed sterile diamond bur, hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this may be repeated up to 3 times (totaling 6 minutes) if necessary. Once bleeding control is established, TheraCal PT material will be placed. According to the manufacturer's instructions, after a 10-second irradiation period, Resin Modified Glass Ionomer Cement (RMCIS) will be applied as a base material (Vitrebond, 3M; ESPE) in a thin layer. Finally, restorative treatment of the tooth will be performed to complete the procedure.