The Success of Root Canal Treatments Performed Using Two Different Intracanal Medicaments

NCT07210177 | Active Not Recruiting

• 1 other identifier: EUDF-ETK-24-6/7
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Previously untreated, asymptomatic, single-rooted maxillary anterior teeth with periapical lesions \<5 mm, no fractures, resorption, calcification, or recent antibiotic use will performed two-visit root canal treatment. Initial radiographs will be taken. After rubber-dam isolation, working length will be determined; canals prepared step-back to size #40 with sodium hypochlorite (NaOCl) irrigation, rinsed and dried. Between appointments, Metapaste or Bio-C TEMP will be placed as intracanal medicament for 7-10 days. At the second appointment medicaments removed, final irrigation performed and root canals obturated and restored. Pain scores recorded at 6h,12h,1d,2d,3d,4d,5d,6d,7d ; follow-ups at 6, 12 and 24 months.

Conditions

Root Canal Treatment; Intracanal Medicament; Post Operative Pain; Apical Periodontitis

Keywords

root canal treatment; chronic apical periodontitis; post operative pain; intracanal medicament

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain

  Following two -visit root canal treatment performed with different intracanal medicament types , the Numerical Rating Scale (NRS) was used to assess both inter-appointment and after obturation. Compare the patients' pain levels, and the patients were instructed to record their pain at 6, 12, 24, 48, and 72 hours, as well as on the 7th day. Patients were informed that a score of 0 represented no pain, while a score of 10 represented the maximum pain, with higher scores indicating greater pain intensity

  Immediately after treatment, between appointments and after obturation for up to 7 days postoperatively

Secondary Outcomes (1)

• Changes in the size and the PAI score of the periapical lesion

  At 6,12 and 24 months after treatment.

Study Arms (2)

Two visit root canal treatment with Bio-C TEMP

ACTIVE COMPARATOR

Two-visit root canal treatment will be performed on the study teeth. Bio-C TEMP (Angelus, Paraná, Brazil), a bioceramic-based intracanal medicament, will be placed in the root canals between appointments according to the manufacturer's instructions.

Other: Bio-C Temp Intracanal Medication

Two visit root canal treatment with Meta Paste

ACTIVE COMPARATOR

Two-visit root canal treatment will be performed on the study teeth. Meta Paste(Meta Biomed Co., Ltd., Chungcheongbuk-do, Korea) a calcium hydroxide based intracanal medicament, will be placed in theroot canals between appointments according to the manufacturer's instructions.

Other: Metapaste Intracanal Medication

Interventions

Bio-C Temp Intracanal Medication OTHER

Bio-C Temp (Angelus, Paraná, Brazil) is a ready-to-use calcium silicate-based material designed for use between appointments. Bio-C Temp is indicated for use as a substitute for calcium hydroxide, as a medicament for necrotic teeth or root canal resurfacing treatments, and for the treatment of internal and external root resorption and immature teeth.

Two visit root canal treatment with Bio-C TEMP

Metapaste Intracanal Medication OTHER

Metapaste (Meta Bıomed Co.,Ltd., Chungcheongbuk-do,Korea) is a ready-to-use calcium hydroxide-based material designed for use between appointments.Metapaste is indicated for use as a medicament for necrotic teeth or root canal resurfacing treatments, and for the treatment of internal and external root resorption and immature teeth.

Two visit root canal treatment with Meta Paste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with a non-contributory medical history, mature maxillary incisor teeth with periapical lesions, diagnosed as asymptomatic apical periodontitis

You may not qualify if:

• clinical symptoms, drainage, more than 5 mm loss of periodontal attachment, Teeth with periapical lesions larger than 5 mm previous endodontic treatment, non-restorable tooth patient with taken antibiotic or analgesics

Sponsors & Collaborators

• Ege University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Ege University

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: August 1, 2024
• Primary Completion: May 29, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)