Periapical; InfectionNCT06307678
Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators
A study testing Calcium Hydroxide and Calcium Silicate in people with Periapical; Infection, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periapical; Infection
- What is being tested?
- Calcium Hydroxide and Calcium Silicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2023to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incisor, canine, and premolar teeth that had previously undergone root canal treatment (cases with persistent and secondary disease) and presented with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis were included. Incisor, canine, and premolar teeth with only 1 root canal were included in the study to avoid untreated extra root canals and difficulties in the preparation, obturation, and restoration of molar teeth and to make treatments more standardized.The patients had not used any antibiotics for 3 months before treatment, and patients were obviously free of systemic diseases.
Who cannot join
- Patients were excluded if teeth showed the presence of a root fracture or any swelling, ankyloses, or periodontal pockets deeper than 4 mm. Teeth on which a rubber dam could not be performed were excluded. Patients with allergy to ibuprofen or ciprofloxacin were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF CALCIUM SILICATE-BASED ROOT CANAL MEDICAMENT ON RELEASE OF BONE RESORPTION AND INFLAMMATION MEDIATORS IN PERIAPICAL LESIONS: A RANDOMISED CONTROLLED CLINICAL TRIAL
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.
The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions.
Read the detailed description
Sixty patients were randomly divided into two groups using a web program according to the medication selected: Calcium silicate based root canal medicament or calcium hydroxide based root canal medicament.
After removing gutta-percha from the root canals, RANKL/OPG, TNF-α, PGE-2 and TGF- β1 samples were taken from the interstitial fluid of the apical tissues using three paper points.
At the second appointment, medicaments were removed and second sampling was performed using the same method. RANKL/OPG, TNF-α, PGE-2 and TGF- β1 levels were measured by enzyme-linked immunosorbent assay and their ratios were calculated.
- Conditions
- Periapical; Infection
- Being tested
- Calcium Hydroxide, Calcium Silicate
- Keywords
- intracanal medicament, intracanal dressing, RANKL, osteoprotegerin, TNF alpha, TGF beta, prostaglandin E2
- Medical subject headings
- Infections, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium HydroxideDrug
Also called calcium hydroxide based medicament group
The samples were taken from the interstitial fluid of the apical tissues using 3 paper points before medicament placement.
Calcium hydroxide based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length.
At the second appointment, medicamentswere removed, and second samplingwas performed using the same method.
The RANKL/OPG, TNF alpha, TGF beta, PGE2 levels were measured by the enzyme-linked immunosorbent assay, and their ratio was calculated.
Calcium SilicateDrug
Also called calcium silicate based medicament group
The samples were taken from the interstitial fluid of the apical tissues using 3 paper points before medicament placement.
Calcium silicate based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. At the second appointment, medicaments were removed, and second sampling was performed using the same method.
The RANKL/OPG, TNF alpha, TGF beta, PGE2 levels were measured by the enzyme-linked immunosorbent assay, and their ratio was calculated.
| Study group | Role | What they receive |
|---|---|---|
| calcium silicate based medicament | Experimental | Root canal lengths were determined by an electronic apex locator with a 15-K file R25 and R50 Reciproc files were used at working lengths to complete the canal preparation. During instrumentation, the root canals were irrigated with 2 mL 1% NaOCl. To obtain the first samples, 3 sterile paper points were placed into the root canals beyond the 2-mm root apex and were kept in position for 60 seconds. Thereafter, the paper points were cut 4 mm from the tip30.
Afterward, root canals were dried with paper points, and calcium silicate based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. Next, the coronal cavities were restored with temporary material.
Seven days later, the medication was mechanically removed using a master apical file. Subsequently, root canals were irrigated.The final samples were collected from the interstitial fluid of the apical tissue as previously described. Receives: Drug: Calcium Silicate |
| calcium hydroxide based medicament | Active comparator | Root canal lengths were determined by an electronic apex locator with a 15-K file R25 and R50 Reciproc files were used at working lengths to complete the canal preparation. During instrumentation, the root canals were irrigated with 2 mL 1% NaOCl. To obtain the first samples, 3 sterile paper points were placed into the root canals beyond the 2-mm root apex and were kept in position for 60 seconds. Thereafter, the paper points were cut 4 mm from the tip30.
Afterward, root canals were dried with paper points, and calcium hydroxide based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. Next, the coronal cavities were restored with temporary material.
Seven days later, the medication was mechanically removed using a master apical file. Subsequently, root canals were irrigated.The final samples were collected from the interstitial fluid of the apical tissue as previously described. Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative and postoperative levels of RANKL/OPG ratio
The amounts of cytokines RANKL and OPG were measured using an enzyme-linked immunosorbent assay kit.
Measured: one week
preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio
The amounts of PGE2 were measured using an enzyme-linked immunosorbent assay kit.
Measured: one week
preoperative and postoperative levels of TNF alpha ratio
The amounts of TNF alpha were measured using an enzyme-linked immunosorbent assay kit.
Measured: one week
preoperative and postoperative levels of TGF beta ratio
The amounts of TGF beta were measured using an enzyme-linked immunosorbent assay kit.
Measured: one week
Secondary outcomes (1)
dependent variables (sex, age, teeth number, smoking habit)
Did the teeth number, age, sex, smoking habit have any effect on pretreatment or posttreatment levels of RANKL/OPG, PGE2, TNF alpha, TGF beta?
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start7 Jul 2023
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical; InfectionStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Model description
- two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Sümbüllü, Ataturk University
- Investigators
- meltem sümbüllü, DDS, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307678
- Sponsor's protocol ID
- AtaturkU-DHF-MS-01
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Unal O, Sumbullu M, Laloglu E. Effect of tricalcium silicate-based intracanal dressing on bone resorption and inflammatory mediators in periapical lesions: a randomized controlled clinical trial. Odontology. 2025 Oct;113(4):1667-1677. doi: 10.1007/s10266-025-01093-6. Epub 2025 Mar 28.
PubMed 40155539
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF CALCIUM SILICATE-BASED ROOT CANAL MEDICAMENT ON RELEASE OF BONE RESORPTION AND INFLAMMATION MEDIATORS IN PERIAPICAL LESIONS: A RANDOMISED CONTROLLED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06307678
- Acronym / sponsor ID
- AtaturkU-DHF-MS-01
- Conditions
- Periapical; Infection
- Keywords
- intracanal medicament, intracanal dressing, RANKL, osteoprotegerin, TNF alpha, TGF beta, prostaglandin E2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 13 Mar 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.
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.
The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions.
Detailed description
Sixty patients were randomly divided into two groups using a web program according to the medication selected: Calcium silicate based root canal medicament or calcium hydroxide based root canal medicament.
After removing gutta-percha from the root canals, RANKL/OPG, TNF-α, PGE-2 and TGF- β1 samples were taken from the interstitial fluid of the apical tissues using three paper points.
At the second appointment, medicaments were removed and second sampling was performed using the same method. RANKL/OPG, TNF-α, PGE-2 and TGF- β1 levels were measured by enzyme-linked immunosorbent assay and their ratios were calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups: group 1 calcium hydroxide based medicament (control group) group 2: calcium silicate based medicament
| Arm | Type | Receives |
|---|---|---|
| calcium silicate based medicament | Experimental | Drug: Calcium SilicateRoot canal lengths were determined by an electronic apex locator with a 15-K file R25 and R50 Reciproc files were used at working lengths to complete the canal preparation. During instrumentation, the root canals were irrigated with 2 mL 1% NaOCl. To obtain the first samples, 3 sterile paper points were placed into the root canals beyond the 2-mm root apex and were kept in position for 60 seconds. Thereafter, the paper points were cut 4 mm from the tip30. Afterward, root canals were dried with paper points, and calcium silicate based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. Next, the coronal cavities were restored with temporary material. Seven days later, the medication was mechanically removed using a master apical file. Subsequently, root canals were irrigated.The final samples were collected from the interstitial fluid of the apical tissue as previously described. |
| calcium hydroxide based medicament | Active comparator | Drug: Calcium HydroxideRoot canal lengths were determined by an electronic apex locator with a 15-K file R25 and R50 Reciproc files were used at working lengths to complete the canal preparation. During instrumentation, the root canals were irrigated with 2 mL 1% NaOCl. To obtain the first samples, 3 sterile paper points were placed into the root canals beyond the 2-mm root apex and were kept in position for 60 seconds. Thereafter, the paper points were cut 4 mm from the tip30. Afterward, root canals were dried with paper points, and calcium hydroxide based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. Next, the coronal cavities were restored with temporary material. Seven days later, the medication was mechanically removed using a master apical file. Subsequently, root canals were irrigated.The final samples were collected from the interstitial fluid of the apical tissue as previously described. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Incisor, canine, and premolar teeth that had previously undergone root canal treatment (cases with persistent and secondary disease) and presented with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis were included. Incisor, canine, and premolar teeth with only 1 root canal were included in the study to avoid untreated extra root canals and difficulties in the preparation, obturation, and restoration of molar teeth and to make treatments more standardized.The patients had not used any antibiotics for 3 months before treatment, and patients were obviously free of systemic diseases.
Key exclusion criteria (1 listed)
- Patients were excluded if teeth showed the presence of a root fracture or any swelling, ankyloses, or periodontal pockets deeper than 4 mm. Teeth on which a rubber dam could not be performed were excluded. Patients with allergy to ibuprofen or ciprofloxacin were also excluded.
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 |
|---|---|---|
| Calcium HydroxideAlso: calcium hydroxide based medicament groupThe samples were taken from the interstitial fluid of the apical tissues using 3 paper points before medicament placement. Calcium hydroxide based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. At the second appointment, medicamentswere removed, and second samplingwas performed using the same method. The RANKL/OPG, TNF alpha, TGF beta, PGE2 levels were measured by the enzyme-linked immunosorbent assay, and their ratio was calculated. | Drug | calcium hydroxide based medicament |
| Calcium SilicateAlso: calcium silicate based medicament groupThe samples were taken from the interstitial fluid of the apical tissues using 3 paper points before medicament placement. Calcium silicate based medicament was placed in the canals using a file at a distance of 1 or 2 mm less than the root canal length. At the second appointment, medicaments were removed, and second sampling was performed using the same method. The RANKL/OPG, TNF alpha, TGF beta, PGE2 levels were measured by the enzyme-linked immunosorbent assay, and their ratio was calculated. | Drug | calcium silicate based medicament |
Primary outcome
preoperative and postoperative levels of RANKL/OPG ratio
Time frame: one week
The amounts of cytokines RANKL and OPG were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of prostaglandinE2 (PGE2) ratio
Time frame: one week
The amounts of PGE2 were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of TNF alpha ratio
Time frame: one week
The amounts of TNF alpha were measured using an enzyme-linked immunosorbent assay kit.
preoperative and postoperative levels of TGF beta ratio
Time frame: one week
The amounts of TGF beta were measured using an enzyme-linked immunosorbent assay kit.
1 secondary outcome
dependent variables (sex, age, teeth number, smoking habit)
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 40155539Unal O, Sumbullu M, Laloglu E. Effect of tricalcium silicate-based intracanal dressing on bone resorption and inflammatory mediators in periapical lesions: a randomized controlled clinical trial. Odontology. 2025 Oct;113(4):1667-1677. doi: 10.1007/s10266-025-01093-6. Epub 2025 Mar 28.
- Individual participant dataSharing planned: No
Related trials for Periapical; Infection
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Enrolling by invitationPhase 4
Nanozymes in Endodontics
Apical Periodontitis, Endodontic Disease
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Not yet recruitingEarly Phase 1
Frankincense Versus Sodium Hypochlorite for Root Canal Disinfection
Pulp Necrosis, Root Canal Infection
Recruiting
Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments
Periapical Periodontitis, Root Canal Infection
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.
meltem sümbüllü, DDS principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxide and Calcium Silicate in people with Periapical; Infection, run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
preoperative and postoperative levels of RANKL/OPG ratio (time frame: one week). The study lists 4 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 NCT06307678, which also lists 1 linked publication.
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 13 Mar 2024.