Evaluating pain after pulp treatment with different materials

Effects of TheraCal PT, Biodentin, and MTA on Postoperative Pain After Full Pulpotomy in Permanent Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial

This study tests which of three different materials used during a tooth treatment can help reduce pain for adults with a specific type of tooth problem.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Cumhuriyet University (Academic / other)
• Locations: 2 sites (Sivas and 1 other locations)
• Trial ID: NCT06880471 on ClinicalTrials.gov

What this trial studies

This study evaluates the postoperative pain experienced by patients undergoing pulpotomy on their lower first molars, using three different biocompatible materials: TheraCal PT, Biodentin, and MTA. A total of 51 participants aged 18 to 45 with symptomatic irreversible pulpitis will be randomly assigned to one of the three treatment groups. The study will assess pain levels following the procedure to determine which material is most effective in reducing discomfort. Statistical analysis will be conducted to compare outcomes across the groups.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 45 with symptomatic irreversible pulpitis in their lower first molars.

Not a fit: Patients with systemic diseases, mental disorders, or those who have recently taken painkillers or antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing pulpotomy.

How similar studies have performed: While similar studies have explored the use of biocompatible materials in dental procedures, this specific comparison of TheraCal PT, Biodentin, and MTA in the context of postoperative pain is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age range should be between 18 and 45,
2. Systemic disease should be absent,
3. Apical periodontitis findings may or may not be present,
4. Irreversible pulpitis symptoms should be present,
5. The apex of the tooth should be closed,
6. Pulp sensitivity tests (cold test and electric pulp test) should respond positively,
7. Periodontal pocket depth and mobility should be within normal limits,
8. Rubber dam isolation should be provided for the tooth to be treated,
9. Restorative treatment of the tooth should be performed,
10. The patient's mouth opening should be sufficient.

Exclusion Criteria:

1. The patient has any systemic disease (including conditions requiring prophylaxis),
2. The patient has mental or psychiatric disorders,
3. The patient has any allergic condition,
4. The patient has used painkillers in the last 12 hours before the procedure and antibiotics in the last week,
5. There is a loss of material in an amount that cannot be restoratively treated,
6. The presence of a fistula tract or abscess,
7. A negative response to pulp sensitivity tests (cold test and electric pulp test),
8. No bleeding in the pulp or failure to achieve hemostasis within 6 minutes after total pulpotomy,
9. The apex is open,
10. Advanced canal calcification is observed on periapical radiography,
11. The presence of internal or external root resorption.

Where this trial is running

Sivas and 1 other locations

• Faculty of Dentistry, Sivas Cumhuriyet University — Sivas, Turkey (Recruiting)
• Sivas Republic University Faculty of Dentistry — Sivas, Turkey (Not_yet_recruiting)

Study contacts

• Study coordinator: Fatoş Albayrak assistant professor

Conditions Symptomatic Irreversible Pulpitis