Endodontically Treated TeethRCTCa(OH)2NCT06447519
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
A study testing Ca(OH)2 as intracanal medicament in people with Endodontically Treated Teeth and Calcium Hydroxide, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endodontically Treated Teeth, Calcium Hydroxide
- What is being tested?
- Ca(OH)2 as intracanal medicament
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGreece
- Study dates
- 12 Sep 2024to 12 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects that do not meet the inclusion criteria
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Dentitry, Aristotle University of Thessaloniki
Thessaloniki, Central Macedonia, 54124
About this study
Official title: Clinical and Radiographic Outcomes of Multiple-Visit Non-Surgical Root Canal Treatment in Permanent Teeth With Symptomatic Apical Periodontitis : Interappointment Dressing or Not? A Randomized Clinical Trial
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.
Read the 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
- Being tested
- Ca(OH)2 as intracanal medicament
- Keywords
- Multivisit Endodontic Treatment, Interapointment dressing, Apical Periodontitis, Outcome
- Medical subject headings
- Tooth, Nonvital, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ca(OH)2 as intracanal medicamentDrug
Ca(OH2 will be used as intracanal medicament for the disinfection of the root canal between appointmnents
| Study group | Role | What they receive |
|---|---|---|
| Ca(OH)2 intracanal medicament | Experimental | Ca(OH)2 intracanal medicament used for root canal disinfection as interapointment dressing. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6-24 months post-operatively
Secondary outcomes (2)
Flare-up incidence
Patients will contact the primary investigator in case of pain or swelling that may appear after each appointment.
Measured: 0 to 3 days after every single appointment
Postoperative pain assesment
Description: Participants will be advised to follow analgesic medication of Ibuprofen (600mg) or Paracetamol (1000mg) treatment or combined medication only in case of feeling pain. Participants will be asked to rate the level of pain on a numerical rating scale from 0 to10 before the start and after 1, 2 and 3 days of each session. According to this scale 0 is indicative of "no pain" and 10 is indicative of "the worst pain ever felt". All intermediate scales are proportional to the pain of the patient. For example, 1 to 3 is indicative of mild pain, 4 to 6 moderate pain and 7 to 9 severe pain. Participants will also be given a paper form in which they must fill in the type and quantity of receiving analgesic medication for each of the first 3 days after each session of endodontic therapy. Besides the numerical pain scale the number of analgesic tablets will be also recorded.
Measured: 0 to 3 days after every single appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start12 Sep 2024
- Primary completion12 Sep 2026 (estimated)
- Study completion12 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos Economides, Prof., Study director, School of Dentistry, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447519
- Sponsor's protocol ID
- 230/21-03-2024
- Acronym
- RCTCa(OH)2
- Status last verified
- Jun 2026
- First submitted
- 27 May 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11307438Paredes-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.
PubMed 22892729Mergoni 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.
PubMed 36512807Rossi-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.
PubMed 35579074
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Multiple-Visit Non-Surgical Root Canal Treatment in Permanent Teeth With Symptomatic Apical Periodontitis : Interappointment Dressing or Not? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06447519
- Acronym / sponsor ID
- RCTCa(OH)2 / 230/21-03-2024
- Conditions
- Endodontically Treated Teeth, Calcium Hydroxide
- Keywords
- Multivisit Endodontic Treatment, Interapointment dressing, Apical Periodontitis, Outcome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 12 Sep 2026 (estimated)
- Study completion
- 12 Sep 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ca(OH)2 intracanal medicament | Experimental | Drug: Ca(OH)2 as intracanal medicamentCa(OH)2 intracanal medicament used for root canal disinfection as interapointment dressing. |
| Standard of Care | No intervention | –No intracanal medicament. The root canal will be left empty without any intracanal dressing between appointments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ASA grade: I or II
- Age: ≥18 years
- Permanent teeth
- Pulp diagnosis: necrosis or previously treated
- Diagnosis of periapical tissues: symptomatic apical periodontitis
Key exclusion criteria (14 listed)
- Subjects that do not meet the inclusion criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ca(OH)2 as intracanal medicamentCa(OH2 will be used as intracanal medicament for the disinfection of the root canal between appointmnents | Drug | Ca(OH)2 intracanal medicament |
Primary outcome
Clinical evidence of success
Time frame: 6-24 months post-operatively
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.
Radiographic evidence of success
Time frame: 6-24 months post-operatively
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.
2 secondary outcomes
Flare-up incidence
Time frame: 0 to 3 days after every single appointment
Postoperative pain assesment
Time frame: 0 to 3 days after every single appointment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 11307438Weiger 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.
- Background: PubMed 22892729Paredes-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.
- Background: PubMed 36512807Mergoni 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.
- Background: PubMed 35579074Rossi-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Economides, Prof. study director
School of Dentistry, Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ca(OH)2 as intracanal medicament in people with Endodontically Treated Teeth and Calcium Hydroxide, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evidence of success (time frame: 6-24 months post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06447519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.