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

NCT06447519 | Recruiting

• 1 other identifier: 230/21-03-2024
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth; Calcium Hydroxide

Keywords

Multivisit Endodontic Treatment; Interapointment dressing; Apical Periodontitis; Outcome

Outcome Measures

Primary Outcomes (2)

• Clinical evidence of success

  Criteria of clinical success include the absence of pain and tenderness to palpation and percussion and the absence of sinus or any associated soft tissue swelling. Failure is indicated by the presence of at least one of the abovementioned signs or symptoms.

  6-24 months post-operatively

• Radiographic evidence of success

  Radiographic evidence of periapical healing will be evaluated by the improvement of Periapical Index score (PAI). The PAI system provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 ( severe periodontitis with exacerbating features). In detail PAI score 1 indicates normal periapical anatomy. PAI score 2 indicates mild changes in bone pattern. PAI score 3 is indicative by changes in bone pattern with diffuse loss of mineral. PAI score 4 is indicative of apical periodontitis with definite radiolucency in the periapical area. PAI score 5 indicates severe periodontitis with exacerbating features. Improvement of PAI score will be evaluated as success. Consequently a lower PAI score is indicative of success but a higher or stable PAI score is indicative of failure.

  6-24 months post-operatively

Secondary Outcomes (2)

• Flare-up incidence

  0 to 3 days after every single appointment

• Postoperative pain assesment

  0 to 3 days after every single appointment

Study Arms (2)

Ca(OH)2 intracanal medicament

EXPERIMENTAL

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

Drug: Ca(OH)2 as intracanal medicament

Standard of Care

NO INTERVENTION

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

Interventions

Ca(OH)2 as intracanal medicament DRUG

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

Ca(OH)2 intracanal medicament

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

School of Dentitry, Aristotle University of Thessaloniki

Thessaloniki, Central Macedonia, 54124, Greece

RECRUITING

Related Publications (4)

• 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.

  PMID: 11307438 BACKGROUND

• 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.

  PMID: 22892729 BACKGROUND

• 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.

  PMID: 36512807 BACKGROUND

• 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.

  PMID: 35579074 BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Nikolaos Economides, Prof.

  School of Dentistry, Aristotle University of Thessaloniki

  STUDY DIRECTOR

Central Study Contacts

Konstantinos Kodonas, Ass.Prof.

CONTACT

00302310999592; kkodonas@dent.auth.gr

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: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 7, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): September 12, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)