Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?

NCT ID: NCT06447519

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-12
• Study Completion Date: 2026-09-12

Brief Summary

The aim of the study is to evaluate the effectiveness of calcium hydroxide as an intracanal medicament in the clinical and radiographic healing of periapical tissues in teeth diagnosed with symptomatic apical periodontitis. This evaluation will be conducted after multiple visit endodontic treatment. The follow-up sessions will be programmed from 6 to 24 months postoperatively. Postoperative pain will also be considered as a secondary outcome. Participants will be asked to rate their pain level on a numerical scale from 0 to10 before and after each session of endodontic treatment. Additionally, the use of analgesics after the procedure will be measured and the incidence of flare-ups will be evaluated. Two study groups will be formed to undergo multiple-visit endodontic treatment. The intervention group will receive intracanal medication of calcium hydroxide, while the control group will have the root canal left empty between appointments.

Detailed Description

The first visit will include the following clinical steps . After administering local anesthesia with 4% articaine hydrochloride and epinephrine injection (with 1:200,000 adrenaline) or 2% mepivacaine for an inferior alveolar block, all decayed tissue from the tooth will be removed. The tooth will be isolated with a rubber dam, the tooth crown will be disinfected with 2% NaOCl, and an access cavity preparation will be created. The #10 C-Pilot file will be used to create a glide path. The working length will be established with an apex locator and an x-ray. The root canal will be instrumented using the sequence of NiTi rotary files Edge Endo X7. The canals will be irrigated copiously with 10ml of 2% NaOCl each time. Following instrumentation, a final rinse with 10ml of 2% NaOCl, 10ml of 17% EDTA, and 10ml of saline solution will be performed. Group 1 will receive intracanal dressing with Ca (OH)2 paste using Lentulo for a period of 7-10 days. Group 2 will be left without intracanal dressing for a period of 7-10 days. In both groups, teeth will be restored with glass ionomer cement (GIC) as a temporary restoration. The final visit will include the following clinical steps. After examining the tooth and surrounding tissues, local anesthesia will be administered as previously described. The temporary restorative material will be removed, and the tooth will be isolated with a rubber dam before accessing the root canal. In Group 1, the intracanal dressing will be removed through irrigation, and then obturated using a standardized, matched size and taper gutta-percha cone with AH-plus sealer with the single-cone obturation technique. The tooth will be then temporarily restored with glass ionomer cement (GIC), and the participant will be referred for final restoration within 7-14 days. The same protocol is followed for Group 2.

Conditions

Endodontically Treated Teeth; Calcium Hydroxide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ca(OH)2 intracanal medicament

Ca(OH)2 intracanal medicament used for root canal disinfection as interapointment dressing.

Group Type: EXPERIMENTAL

Ca(OH)2 as intracanal medicament

Intervention Type: DRUG

Ca(OH2 will be used as intracanal medicament for the disinfection of the root canal between appointmnents

Standard of Care

No intracanal medicament. The root canal will be left empty without any intracanal dressing between appointments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ca(OH)2 as intracanal medicament

Ca(OH2 will be used as intracanal medicament for the disinfection of the root canal between appointmnents

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ASA grade: I or II
• Age: ≥18 years
• Permanent teeth
• Pulp diagnosis: necrosis or previously treated
• Diagnosis of periapical tissues: symptomatic apical periodontitis
• Teeth sensitive to percussion and/or palpation
• Initial PAI: 3-5
• Signed Patient Consent Statement for participation in clinical research

• Pregnant women
• Patients who receive corticosteroids and/or have received antibiotics within the previous three months
• Patients who report pain in a different area than that of the tooth under investigation
• Teeth that cannot be isolated with a rubber dam
• Teeth with extensive hard tissue destruction that is not restorable
• Teeth with an anatomic peculiarity of the root canal (internal resorption, perforation, displacement of root canal course due to previous endodontic treatment)
• Teeth in which the formation of the apex has not been completed
• Fractured teeth with periodontal involvement
• Teeth with periodontal pocket depth ≥ 4mm or teeth with bone loss at the bifurcation of the roots due to periodontitis
• Teeth with loss of periodontal attachment ≥ 5 mm
• Teeth with embedded exudate in the session planned for root canal obturation.
• Teeth that after completion of the endodontic treatment show underocclusion >2mm or hyperobstruction >1mm from the radiographic apex.
• Teeth in which permanent restoration has not been completed over time less than one month after endodontic treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikolaos Economides, Prof.

Role: STUDY_DIRECTOR

School of Dentistry, Aristotle University of Thessaloniki

Locations

School of Dentitry, Aristotle University of Thessaloniki

Thessaloniki, Central Macedonia, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Konstantinos Kodonas, Ass.Prof.

Role: CONTACT

kkodonas@dent.auth.gr

00302310999592

Facility Contacts

Konstantinos Kodonas, Ass.Prof.

Role: primary

kkodonas@dent.auth.gr

Nikolaos Economides, Professor

Role: backup

econom@dent.auth.gr

00302301999592

References

Weiger R, Rosendahl R, Lost C. Influence of calcium hydroxide intracanal dressings on the prognosis of teeth with endodontically induced periapical lesions. Int Endod J. 2000 May;33(3):219-26. doi: 10.1046/j.1365-2591.1999.00298.x.

Reference Type: BACKGROUND

PMID: 11307438 (View on PubMed)

Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.

Reference Type: BACKGROUND

PMID: 22892729 (View on PubMed)

Mergoni G, Ganim M, Lodi G, Figini L, Gagliani M, Manfredi M. Single versus multiple visits for endodontic treatment of permanent teeth. Cochrane Database Syst Rev. 2022 Dec 13;12(12):CD005296. doi: 10.1002/14651858.CD005296.pub4.

Reference Type: BACKGROUND

PMID: 36512807 (View on PubMed)

Rossi-Fedele G, Rodig T. Effectiveness of root canal irrigation and dressing for the treatment of apical periodontitis: A systematic review and meta-analysis of clinical trials. Int Endod J. 2023 Oct;56 Suppl 3:422-435. doi: 10.1111/iej.13777. Epub 2022 May 31.

Reference Type: BACKGROUND

PMID: 35579074 (View on PubMed)

Study Documents

Document Type: Study Protocol

https://ikee.lib.auth.gr

View Document

Other Identifiers

230/21-03-2024

Identifier Type: -

Identifier Source: org_study_id