Apical PeriodontitisNCT07106307
Evaluation of Different Root Canal Obturation Techniques
A study testing Bioceramic Sealer, Warm Vertical Compaction and Epoxy Resin-Based Sealer in people with Apical Periodontitis and Periapical Lesion, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to evaluate the effect of root canal filling, which is the last stage of root canal treatment (RCT), on the post-operative pain level on single rooted permanent teeth with wide lesions with apical periodontitis, and the effect on the healing of the periapical tissue and lesion by… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Apical Periodontitis, Periapical Lesion
- What is being tested?
- Bioceramic Sealer, Warm Vertical Compaction and Epoxy Resin-Based Sealer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 15 May 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Single rooted anterior and premolar teeth with radiographically confirmed periapical lesions classified as Periapical Index (PAI) scores of 4 or 5 will be included in the analysis
- Age between 18 and 60 years
- Systemically healthy individuals
- To be able to read and sign the informed consent form
- Physical and mental fitness to undergo treatment
- Willingness to attend all follow-up sessions
Who cannot join
- Patients with systemic diseases classified as ASA III or higher
- Presence of severe periodontal disease (probing depth >4 mm)
- Use of analgesics within the last 12 hours or antibiotics within the past month before the treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Faculty of Dentistry
Istanbul, Esenler
About this study
Official title: Evaluation of the Effect of Different Root Canal Obturation Techniques on the Success of Root Canal Treatment in Teeth With Apical Periodontitis
The aim of this clinical study is to evaluate the effect of root canal filling, which is the last stage of root canal treatment (RCT), on the post-operative pain level on single rooted permanent teeth with wide lesions with apical periodontitis, and the effect on the healing of the periapical tissue and lesion by comparing periapical radyography images, which was taken at the beginning and after one year.
Read the detailed description
This study aims to evaluate the impact of different root canal filling techniques on postoperative pain levels and the healing of periapical tissues in teeth with periapical lesions, using periapical radiographic imaging. Specifically, the effects of resin-based sealers, bioceramic-based sealers, and two obturation techniques-cold lateral compaction and warm vertical compaction-will be compared. Postoperative pain will be assessed using VAS (Visual Analog Scale) and VRS (Verbal Rating Scale) following the final stage of root canal treatment in incisor and premolar teeth with single roots. Additionally, the healing of periapical lesions will be evaluated by comparing periapical radiographs taken at baseline and at a one-year follow-up. To date, no study has been found in the literature that evaluates these specific combinations of materials and techniques using periapical radiographic imaging.
The study includes four experimental groups based on the combination of obturation technique and sealer type as follows:
Group 1: Cold lateral compaction with AH Plus (epoxy resin-based sealer)
Group 2: Cold lateral compaction with AH Plus Bioceramic (calcium silicate-based sealer)
Group 3: Warm vertical compaction with AH Plus
Group 4: Warm vertical compaction with AH Plus Bioceramic
All treatments will be performed under standardized clinical conditions by an experienced endodontist using a rubber dam in aseptic conditions. Chemomechanical preparation will be done using rotary NiTi instruments and an irrigant protocol consisting of Sodium Hypochlorite (NaOCl), Ethylenediaminetetraacetic Acid (EDTA), and distilled water using Ultrasonic irrigation device. Root canal filling will be performed in a single visit for all patients.
VAS and VRS scores will be recorded at multiple time points postoperatively: immediately after treatment, and at 6, 12, 18, 24, 48, and 72 hours, as well as at 1 week and 1 month. Pain diaries will be provided to all participants.
Radiographic evaluation will be performed using standardized periapical radiographs taken with a parallel technique. Periapical healing will be assessed by comparing lesion size at baseline and at 1 year by two blinded observers.
This study aims to provide clinical data that may guide endodontic decision-making regarding the choice of sealer and obturation technique, particularly in teeth with pre-existing periapical pathology.
- Conditions
- Apical Periodontitis, Periapical Lesion
- Being tested
- Bioceramic Sealer, Warm Vertical Compaction, Epoxy Resin-Based Sealer, Cold Lateral Compaction
- Keywords
- Apical Periodontitis, Periapical Healing, Bioseramic sealer, Epoxy Resin Based Sealer, Warm Vertical Compaction
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioceramic SealerOther
This intervention involves the use of Bioceramic Sealer during root canal obturation. The sealer will be combined with the cold lateral compaction or warm vertical compaction technique depending on the study arm.
Warm Vertical CompactionProcedure or surgery
Warm vertical obturation is performed using a heat delivery device, which thermosoftens gutta-percha and allows vertical compaction into the root canal system. This technique will be used in combination with either resin-based or bioceramic sealers, depending on the study group.
Epoxy Resin-Based SealerOther
This intervention involves the use of an epoxy resin-based root canal sealer during root canal obturation. The material will be applied in combination with either cold lateral compaction or warm vertical compaction techniques, depending on the study group.
Cold Lateral CompactionProcedure or surgery
Cold lateral compaction is a root canal obturation technique in which a master gutta-percha cone is placed to working length and compacted laterally using a finger spreader. This method will be used in combination with either resin-based or bioceramic sealers, depending on the study group.
| Study group | Role | What they receive |
|---|---|---|
| Cold lateral compaction with AH Plus (Epoxy Resin Based Sealer) | Experimental | Root canal obturation will be performed using the cold lateral compaction technique with AH Plus epoxy-resin based sealer. Receives: Other: Epoxy Resin-Based Sealer; Procedure: Cold Lateral Compaction |
| Cold lateral compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer) | Experimental | Root canal obturation will be performed using the cold lateral compaction technique with AH Plus Bioceramic sealer. Receives: Other: Bioceramic Sealer; Procedure: Cold Lateral Compaction |
| Warm vertical compaction with AH Plus (Epoxy Resin Based Sealer) | Experimental | Root canal obturation will be performed using the warm vertical compaction technique with AH Plus epoxy-resin based sealer. Receives: Procedure: Warm Vertical Compaction; Other: Epoxy Resin-Based Sealer |
| Warm vertical compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer) | Experimental | Root canal obturation will be performed using the warm vertical compaction technique with AH Plus Bioceramic sealer. Receives: Other: Bioceramic Sealer; Procedure: Warm Vertical Compaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical Healing
The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).
Measured: From end of treatment to 1 year
Secondary outcomes (2)
Post Operative Pain İntensity
The secondary outcome is postoperative pain intensity. Pain will be assessed at multiple time points (6, 12, 18, 24, 48, and 72 hours, and at 1 week and 1 month post-treatment) using Visual Analog Scale (VAS) where 0 represents "no pain" and 10 represents "worst imaginable pain".
Measured: From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment
Post Operative Pain Intensity
The secondary outcome is postoperative pain intensity. Pain will be assessed at multiple time points (6, 12, 18, 24, 48, and 72 hours, and at 1 week and 1 month post-treatment) using Verbal Rating Scale (VRS), which categorizes pain into four levels: 0 (no pain), 1 (mild), 2 (moderate), and 3 (severe).
Measured: From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Nov 2023
- Primary completion15 May 2025
- Study completion15 May 2025
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 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASLI USTA TAHMAZ, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106307
- Sponsor's protocol ID
- E-10840098-772.02-6496
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD), including all IPD that underlie the results reported in the publication
Publications
Tahmaz AU, Ersahan S, Erkan E, Hepsenoglu YE, Ozcelik F, Tekin A, Gundogar M. Endodontic treatment outcomes in apical periodontitis cases by the lateral condensation versus warm vertical compaction techniques: a one-year follow-up study. BMC Oral Health. 2026 Apr 30;26(1):1164. doi: 10.1186/s12903-026-08425-0.
PubMed 42063099
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Root Canal Obturation Techniques on the Success of Root Canal Treatment in Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07106307
- Acronym / sponsor ID
- E-10840098-772.02-6496
- Conditions
- Apical Periodontitis, Periapical Lesion
- Keywords
- Apical Periodontitis, Periapical Healing, Bioseramic sealer, Epoxy Resin Based Sealer, Warm Vertical Compaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 6 Aug 2025 (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 this clinical study is to evaluate the effect of root canal filling, which is the last stage of root canal treatment (RCT), on the post-operative pain level on single rooted permanent teeth with wide lesions with apical periodontitis, and the effect on the healing of the periapical tissue and lesion by comparing periapical radyography images, which was taken at the beginning and after one year.
Detailed description
This study aims to evaluate the impact of different root canal filling techniques on postoperative pain levels and the healing of periapical tissues in teeth with periapical lesions, using periapical radiographic imaging. Specifically, the effects of resin-based sealers, bioceramic-based sealers, and two obturation techniques-cold lateral compaction and warm vertical compaction-will be compared. Postoperative pain will be assessed using VAS (Visual Analog Scale) and VRS (Verbal Rating Scale) following the final stage of root canal treatment in incisor and premolar teeth with single roots. Additionally, the healing of periapical lesions will be evaluated by comparing periapical radiographs taken at baseline and at a one-year follow-up. To date, no study has been found in the literature that evaluates these specific combinations of materials and techniques using periapical radiographic imaging.
The study includes four experimental groups based on the combination of obturation technique and sealer type as follows:
Group 1: Cold lateral compaction with AH Plus (epoxy resin-based sealer)
Group 2: Cold lateral compaction with AH Plus Bioceramic (calcium silicate-based sealer)
Group 3: Warm vertical compaction with AH Plus
Group 4: Warm vertical compaction with AH Plus Bioceramic
All treatments will be performed under standardized clinical conditions by an experienced endodontist using a rubber dam in aseptic conditions. Chemomechanical preparation will be done using rotary NiTi instruments and an irrigant protocol consisting of Sodium Hypochlorite (NaOCl), Ethylenediaminetetraacetic Acid (EDTA), and distilled water using Ultrasonic irrigation device. Root canal filling will be performed in a single visit for all patients.
VAS and VRS scores will be recorded at multiple time points postoperatively: immediately after treatment, and at 6, 12, 18, 24, 48, and 72 hours, as well as at 1 week and 1 month. Pain diaries will be provided to all participants.
Radiographic evaluation will be performed using standardized periapical radiographs taken with a parallel technique. Periapical healing will be assessed by comparing lesion size at baseline and at 1 year by two blinded observers.
This study aims to provide clinical data that may guide endodontic decision-making regarding the choice of sealer and obturation technique, particularly in teeth with pre-existing periapical pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cold lateral compaction with AH Plus (Epoxy Resin Based Sealer) | Experimental | Other: Epoxy Resin-Based Sealer, Procedure: Cold Lateral CompactionRoot canal obturation will be performed using the cold lateral compaction technique with AH Plus epoxy-resin based sealer. |
| Cold lateral compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer) | Experimental | Other: Bioceramic Sealer, Procedure: Cold Lateral CompactionRoot canal obturation will be performed using the cold lateral compaction technique with AH Plus Bioceramic sealer. |
| Warm vertical compaction with AH Plus (Epoxy Resin Based Sealer) | Experimental | Procedure: Warm Vertical Compaction, Other: Epoxy Resin-Based SealerRoot canal obturation will be performed using the warm vertical compaction technique with AH Plus epoxy-resin based sealer. |
| Warm vertical compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer) | Experimental | Other: Bioceramic Sealer, Procedure: Warm Vertical CompactionRoot canal obturation will be performed using the warm vertical compaction technique with AH Plus Bioceramic sealer. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Single rooted anterior and premolar teeth with radiographically confirmed periapical lesions classified as Periapical Index (PAI) scores of 4 or 5 will be included in the analysis
- Age between 18 and 60 years
- Systemically healthy individuals
- To be able to read and sign the informed consent form
- Physical and mental fitness to undergo treatment
Key exclusion criteria (3 listed)
- Patients with systemic diseases classified as ASA III or higher
- Presence of severe periodontal disease (probing depth >4 mm)
- Use of analgesics within the last 12 hours or antibiotics within the past month before the treatment
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 |
|---|---|---|
| Bioceramic SealerThis intervention involves the use of Bioceramic Sealer during root canal obturation. The sealer will be combined with the cold lateral compaction or warm vertical compaction technique depending on the study arm. | Other | Cold lateral compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer), Warm vertical compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer) |
| Warm Vertical CompactionWarm vertical obturation is performed using a heat delivery device, which thermosoftens gutta-percha and allows vertical compaction into the root canal system. This technique will be used in combination with either resin-based or bioceramic sealers, depending on the study group. | Procedure or surgery | Warm vertical compaction with AH Plus (Epoxy Resin Based Sealer), Warm vertical compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer) |
| Epoxy Resin-Based SealerThis intervention involves the use of an epoxy resin-based root canal sealer during root canal obturation. The material will be applied in combination with either cold lateral compaction or warm vertical compaction techniques, depending on the study group. | Other | Cold lateral compaction with AH Plus (Epoxy Resin Based Sealer), Warm vertical compaction with AH Plus (Epoxy Resin Based Sealer) |
| Cold Lateral CompactionCold lateral compaction is a root canal obturation technique in which a master gutta-percha cone is placed to working length and compacted laterally using a finger spreader. This method will be used in combination with either resin-based or bioceramic sealers, depending on the study group. | Procedure or surgery | Cold lateral compaction with AH Plus (Epoxy Resin Based Sealer), Cold lateral compaction with AH Plus Bioceramic (Calcium Silicate Based Sealer) |
Primary outcome
Periapical Healing
Time frame: From end of treatment to 1 year
The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).
2 secondary outcomes
Post Operative Pain İntensity
Time frame: From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment
Post Operative Pain Intensity
Time frame: From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal 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 6 Aug 2025.
- Derived from this study: PubMed 42063099Tahmaz AU, Ersahan S, Erkan E, Hepsenoglu YE, Ozcelik F, Tekin A, Gundogar M. Endodontic treatment outcomes in apical periodontitis cases by the lateral condensation versus warm vertical compaction techniques: a one-year follow-up study. BMC Oral Health. 2026 Apr 30;26(1):1164. doi: 10.1186/s12903-026-08425-0.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD), including all IPD that underlie the results reported in the publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioceramic Sealer, Warm Vertical Compaction and Epoxy Resin-Based Sealer in people with Apical Periodontitis and Periapical Lesion, run by Medipol 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 6 inclusion and 3 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 6 Aug 2025. 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?
Periapical Healing (time frame: From end of treatment to 1 year). 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 NCT07106307, 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 6 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.