Apical PeriodontitisNCT07339579
Sealers in Chronic Apical Lesions
A study testing Root Canal Treatment With Sealapex, Root Canal Treatment With MTA Fillapex and Root Canal Treatment With AH Plus in people with Apical Periodontitis and Postoperative Pain, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study evaluated whether different root canal sealers influence postoperative pain and early periapical healing in patients with apical periodontitis. A total of 72 adult patients with single-rooted teeth diagnosed with chronic apical periodontitis received standardized root canal treatment and were… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apical Periodontitis, Postoperative Pain, Periapical Healing
- What is being tested?
- Root Canal Treatment With Sealapex, Root Canal Treatment With MTA Fillapex and Root Canal Treatment With AH Plus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Sep 2025
- 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
- Adults aged 18 to 65 years
- Patients diagnosed with apical periodontitis
- Presence of a single-rooted anterior or premolar tooth with a radiographically visible periapical lesion
- Systemically healthy individuals classified as ASA I or ASA II
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Teeth with root fractures, external resorption, or open apices
- Calcified canals or severely curved root canals (>30°)
- Periodontal pocket depth greater than 3 mm
- Pregnancy
- Use of antibiotics or analgesics within the previous 7 days
- History of previous endodontic treatment or retreatment in the study tooth
- Presence of systemic conditions that could affect healing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sutcu İmam University, Faculty of Dentistry
Kahramanmaraş, onikişubat, 46010
About this study
Official title: Evaluation of the Effects of Root Canal Sealers on Postoperative Pain and Radiographic Healing in Patients With Apical Periodontitis
This clinical study evaluated whether different root canal sealers influence postoperative pain and early periapical healing in patients with apical periodontitis. A total of 72 adult patients with single-rooted teeth diagnosed with chronic apical periodontitis received standardized root canal treatment and were randomly assigned to one of three commonly used sealers: AH Plus, MTA Fillapex, or Sealapex.
Postoperative pain was recorded using a verbal pain rating scale immediately after treatment and at 24 and 72 hours. Periapical healing was assessed at baseline and after six months using periapical radiographs and cone-beam computed tomography (CBCT).
The purpose of this study was to determine whether the type of root canal sealer affects patient comfort after treatment and the early healing of periapical tissues. Understanding these outcomes may help clinicians choose appropriate materials and better inform patients about expected pain and healing after root canal therapy.
Read the detailed description
This study was designed as a single-center, randomized, controlled clinical trial to compare the effects of three different root canal sealers on postoperative pain and radiographic periapical healing in patients with apical periodontitis.
A total of 72 patients aged 18-65 years with single-rooted anterior or premolar teeth diagnosed with chronic apical periodontitis were enrolled. Patients with systemic diseases beyond ASA I-II status, previous endodontic treatment, root fractures, severe canal curvature, open apices, or recent use of antibiotics or analgesics were excluded to ensure standardization.
After obtaining informed consent, participants were randomly allocated into three equal groups according to the sealer used for root canal obturation: Sealapex (calcium hydroxide-based sealer), MTA Fillapex (MTA-containing salicylate resin-based sealer), or AH Plus (epoxy resin-based sealer). All root canal treatments were performed in a single visit under rubber dam isolation by the same experienced endodontist to eliminate inter-operator variability.
Root canals were prepared using a standardized nickel-titanium instrumentation system and irrigated with sodium hypochlorite and EDTA according to a uniform protocol. Obturation was completed using the lateral condensation technique with gutta-percha and the assigned sealer. Permanent composite restorations were placed after obturation.
Postoperative pain was assessed using the Verbal Rating Scale (VRS) immediately after treatment and at 24 and 72 hours. Patients were instructed not to use analgesics unless severe pain occurred.
Radiographic evaluation of periapical healing was performed using periapical radiographs and cone-beam computed tomography (CBCT) at baseline and at the 6-month follow-up. Healing was assessed using the Periapical Index (PAI) and three-dimensional CBCT evaluation to detect early changes in lesion size and bone repair.
The primary objective of the study was to compare postoperative pain levels among the three sealer groups. Secondary objectives included evaluation of early periapical healing using both two-dimensional and three-dimensional imaging methods.
This study aimed to clarify whether sealer composition influences short-term clinical outcomes when root canal treatment is performed under standardized conditions. The findings may contribute to evidence-based material selection and improved patient counseling regarding postoperative pain and healing expectations.
- Conditions
- Apical Periodontitis, Postoperative Pain, Periapical Healing
- Being tested
- Root Canal Treatment With Sealapex, Root Canal Treatment With MTA Fillapex, Root Canal Treatment With AH Plus
- Keywords
- Root Canal Sealer, AH Plus, MTA Fillapex, Sealapex, Root Canal Treatment, Periapical Index, Cone-Beam Computed Tomography, Postoperative Pain, Endodontics
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Canal Treatment With SealapexProcedure or surgery
Root canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with Sealapex (calcium hydroxide-based sealer).
Root Canal Treatment With MTA FillapexProcedure or surgery
Root canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with MTA Fillapex (MTA-containing salicylate resin-based sealer).
Root Canal Treatment With AH PlusProcedure or surgery
Root canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with AH Plus (epoxy resin-based sealer).
| Study group | Role | What they receive |
|---|---|---|
| Sealapex Group | Experimental | Participants received standardized single-visit root canal treatment using Sealapex as the root canal sealer during obturation. Receives: Procedure: Root Canal Treatment With Sealapex |
| MTA Fillapex Group | Experimental | Participants received standardized single-visit root canal treatment using MTA Fillapex as the root canal sealer during obturation. Receives: Procedure: Root Canal Treatment With MTA Fillapex |
| AH Plus Group | Experimental | Participants received standardized single-visit root canal treatment using AH Plus as the root canal sealer during obturation. Receives: Procedure: Root Canal Treatment With AH Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by Verbal Rating Scale (VRS)
Postoperative pain intensity was evaluated using the Verbal Rating Scale (VRS). Patients were asked to verbally rate their pain according to the following categories:
0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain.
Measured: Immediately after treatment, 24 hours, and 72 hours after root canal treatment
Secondary outcomes (2)
Periapical Healing Assessed by Cone-Beam Computed Tomography (CBCT)
Periapical healing was evaluated using cone-beam computed tomography (CBCT). CBCT images were analyzed to assess changes in periapical lesion size and bone healing by comparing baseline and follow-up scans.
Healing was determined based on reduction or resolution of periapical radiolucency, assessed in coronal, sagittal, and axial sections, and supported by three-dimensional reconstruction.
Image evaluation was performed by blinded examiners using standardized criteria.
Measured: Baseline and 6 months after treatment
Periapical Healing Assessed by Periapical Index (PAI)
Periapical healing was assessed using the Periapical Index (PAI) based on standardized periapical radiographs.
Radiographic findings were scored according to the five-point PAI scale as follows:
- = normal periapical structures,
- = small changes in bone structure,
- = changes in bone structure with some mineral loss,
- = periodontitis with a well-defined radiolucent area, and
- = severe apical periodontitis with exacerbating features.
Changes in periapical status were evaluated by comparing baseline and 6-month follow-up images. Radiographic assessments were performed by blinded examiners using standardized evaluation criteria.
Measured: Baseline and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies 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
- Model description
- Participants were randomly assigned to one of three parallel intervention groups according to the root canal sealer used during treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliye Kamalak, Kahramanmaras Sutcu Imam University
- Investigators
- Aliye Kamalak, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339579
- Sponsor's protocol ID
- KSU-SEALER-AP-2024
- Other IDs
- 51 (22/07/2024)
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Root Canal Sealers on Postoperative Pain and Radiographic Healing in Patients With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07339579
- Acronym / sponsor ID
- KSU-SEALER-AP-2024
- Conditions
- Apical Periodontitis, Postoperative Pain, Periapical Healing
- Keywords
- Root Canal Sealer, AH Plus, MTA Fillapex, Sealapex, Root Canal Treatment, Periapical Index, Cone-Beam Computed Tomography, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 14 Jan 2026 (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.
This clinical study evaluated whether different root canal sealers influence postoperative pain and early periapical healing in patients with apical periodontitis. A total of 72 adult patients with single-rooted teeth diagnosed with chronic apical periodontitis received standardized root canal treatment and were randomly assigned to one of three commonly used sealers: AH Plus, MTA Fillapex, or Sealapex.
Postoperative pain was recorded using a verbal pain rating scale immediately after treatment and at 24 and 72 hours. Periapical healing was assessed at baseline and after six months using periapical radiographs and cone-beam computed tomography (CBCT).
The purpose of this study was to determine whether the type of root canal sealer affects patient comfort after treatment and the early healing of periapical tissues. Understanding these outcomes may help clinicians choose appropriate materials and better inform patients about expected pain and healing after root canal therapy.
Detailed description
This study was designed as a single-center, randomized, controlled clinical trial to compare the effects of three different root canal sealers on postoperative pain and radiographic periapical healing in patients with apical periodontitis.
A total of 72 patients aged 18-65 years with single-rooted anterior or premolar teeth diagnosed with chronic apical periodontitis were enrolled. Patients with systemic diseases beyond ASA I-II status, previous endodontic treatment, root fractures, severe canal curvature, open apices, or recent use of antibiotics or analgesics were excluded to ensure standardization.
After obtaining informed consent, participants were randomly allocated into three equal groups according to the sealer used for root canal obturation: Sealapex (calcium hydroxide-based sealer), MTA Fillapex (MTA-containing salicylate resin-based sealer), or AH Plus (epoxy resin-based sealer). All root canal treatments were performed in a single visit under rubber dam isolation by the same experienced endodontist to eliminate inter-operator variability.
Root canals were prepared using a standardized nickel-titanium instrumentation system and irrigated with sodium hypochlorite and EDTA according to a uniform protocol. Obturation was completed using the lateral condensation technique with gutta-percha and the assigned sealer. Permanent composite restorations were placed after obturation.
Postoperative pain was assessed using the Verbal Rating Scale (VRS) immediately after treatment and at 24 and 72 hours. Patients were instructed not to use analgesics unless severe pain occurred.
Radiographic evaluation of periapical healing was performed using periapical radiographs and cone-beam computed tomography (CBCT) at baseline and at the 6-month follow-up. Healing was assessed using the Periapical Index (PAI) and three-dimensional CBCT evaluation to detect early changes in lesion size and bone repair.
The primary objective of the study was to compare postoperative pain levels among the three sealer groups. Secondary objectives included evaluation of early periapical healing using both two-dimensional and three-dimensional imaging methods.
This study aimed to clarify whether sealer composition influences short-term clinical outcomes when root canal treatment is performed under standardized conditions. The findings may contribute to evidence-based material selection and improved patient counseling regarding postoperative pain and healing expectations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel intervention groups according to the root canal sealer used during treatment.
| Arm | Type | Receives |
|---|---|---|
| Sealapex Group | Experimental | Procedure: Root Canal Treatment With SealapexParticipants received standardized single-visit root canal treatment using Sealapex as the root canal sealer during obturation. |
| MTA Fillapex Group | Experimental | Procedure: Root Canal Treatment With MTA FillapexParticipants received standardized single-visit root canal treatment using MTA Fillapex as the root canal sealer during obturation. |
| AH Plus Group | Experimental | Procedure: Root Canal Treatment With AH PlusParticipants received standardized single-visit root canal treatment using AH Plus as the root canal sealer during obturation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years
- Patients diagnosed with apical periodontitis
- Presence of a single-rooted anterior or premolar tooth with a radiographically visible periapical lesion
- Systemically healthy individuals classified as ASA I or ASA II
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (7 listed)
- Teeth with root fractures, external resorption, or open apices
- Calcified canals or severely curved root canals (>30°)
- Periodontal pocket depth greater than 3 mm
- Pregnancy
- Use of antibiotics or analgesics within the previous 7 days
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 |
|---|---|---|
| Root Canal Treatment With SealapexRoot canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with Sealapex (calcium hydroxide-based sealer). | Procedure or surgery | Sealapex Group |
| Root Canal Treatment With MTA FillapexRoot canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with MTA Fillapex (MTA-containing salicylate resin-based sealer). | Procedure or surgery | MTA Fillapex Group |
| Root Canal Treatment With AH PlusRoot canal treatment was performed under standardized clinical conditions, and canals were obturated using gutta-percha with AH Plus (epoxy resin-based sealer). | Procedure or surgery | AH Plus Group |
Primary outcome
Postoperative Pain Intensity Assessed by Verbal Rating Scale (VRS)
Time frame: Immediately after treatment, 24 hours, and 72 hours after root canal treatment
Postoperative pain intensity was evaluated using the Verbal Rating Scale (VRS). Patients were asked to verbally rate their pain according to the following categories: 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain.
2 secondary outcomes
Periapical Healing Assessed by Cone-Beam Computed Tomography (CBCT)
Time frame: Baseline and 6 months after treatment
Periapical Healing Assessed by Periapical Index (PAI)
Time frame: Baseline and 6 months after treatment
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 14 Jan 2026.
- 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.
Aliye Kamalak principal investigator
Kahramanmaras Sutcu Imam 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 Root Canal Treatment With Sealapex, Root Canal Treatment With MTA Fillapex and Root Canal Treatment With AH Plus in people with Apical Periodontitis and Postoperative Pain, run by Kahramanmaras Sutcu Imam 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 5 inclusion and 7 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 14 Jan 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 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?
Postoperative Pain Intensity Assessed by Verbal Rating Scale (VRS) (time frame: Immediately after treatment, 24 hours, and 72 hours after root canal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026.