Single-visitNCT07868315
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
A study testing One-Fill, TotalFill and AH Plus + Single Cone in people with Single-visit and Periapical Periodontitis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the postoperative pain and long-term clinical and radiographic success of single-visit primary root canal treatment in asymptomatic teeth with periapical lesions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Single-visit, Periapical Periodontitis
- What is being tested?
- One-Fill, TotalFill and AH Plus + Single Cone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2025to 10 Nov 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years.
- Patients classified as ASA Physical Status I or II according to the American Society of Anesthesiologists (ASA) classification:
- Teeth that have not previously undergone root canal retreatment or surgical intervention.
- Patients who are able to read and sign the informed consent form.
- Patients who are physically and mentally able to tolerate the planned dental treatment.
- Teeth treated in a single treatment session.
Who cannot join
- Pregnant or lactating women.
- Patients with chronic periodontal disease and/or a periodontal probing depth >4 mm.
- Symptomatic patients.
- Patients who are unable to comply with the scheduled follow-up periods.
- Patients who have used analgesics within 1 week or antibiotics within 1 month prior to treatment.
- Teeth with root resorption.
- Teeth with a vertical root fracture or a risk of vertical root fracture.
- Teeth with incomplete root development.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University, Faculty of Dentistry
Istanbul, Esenler
Yelda Erdem Hepsenoglu, PhD, 00905054104563, yelda_erdem89@hotmail.com
About this study
This study evaluates the postoperative pain and long-term clinical and radiographic success of single-visit primary root canal treatment in asymptomatic teeth with periapical lesions.
Read the detailed description
A total of 200 patients will be evaluated and divided into four treatment groups according to the root canal filling material and technique: AH Plus with warm gutta-percha, AH Plus with the single-cone technique, TotalFill BC Sealer with the single-cone technique, and One-Fil with the single-cone technique. Postoperative pain will be assessed, while periapical healing will be evaluated clinically and radiographically using the Periapical Index (PAI) during follow-up visits extending from 1 month to 1 year. The study aims to compare different root canal sealers and obturation techniques and contribute to the understanding of their long-term treatment outcomes.
- Conditions
- Single-visit, Periapical Periodontitis
- Being tested
- One-Fill, TotalFill, AH Plus + Single Cone, AH Plus + Continuous Wave
- Keywords
- treatment outcome, periapical health, post operative pain, periapical index, Chronic apical periodontitis
- 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.
One-FillOther
Root canal obturation using One-Fill bioceramic sealer with a single-cone technique. The prepared root canal is filled with a fitted gutta-percha cone coated with One-Fill sealer according to the manufacturer's instructions.
TotalFillOther
Root canal obturation using TotalFill BC Sealer with a single-cone technique. The prepared root canal is filled with a fitted gutta-percha cone coated with TotalFill BC Sealer according to the manufacturer's instructions.
AH Plus + Single ConeOther
Root canal obturation using AH Plus epoxy resin-based sealer with a single-cone technique. A fitted gutta-percha cone is coated with AH Plus sealer and placed to the working length according to the study protocol.
AH Plus + Continuous WaveOther
Root canal obturation using AH Plus epoxy resin-based sealer with the continuous wave of condensation technique. The master gutta-percha cone is fitted to the working length, followed by down-pack and backfill procedures using heated gutta-percha according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| One Fill | Experimental | Root canal obturation using One Fill root canal sealer according to the manufacturer's instructions. Receives: Other: One-Fill |
| TotalFill | Experimental | Root canal obturation using TotalFill root canal sealer according to the manufacturer's instructions. Receives: Other: TotalFill |
| AH Plus + Single Cone | Experimental | Root canal obturation using AH Plus root canal sealer in combination with a single-cone obturation technique. Receives: Other: AH Plus + Single Cone |
| AH Plus + Continuous Wave | Experimental | Root canal obturation using AH Plus root canal sealer in combination with a continuous-wave obturation technique. Receives: Other: AH Plus + Continuous Wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Postoperative pain following single-session primary root canal treatment, assessed using a 10-point visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. higher scores indicate greater pain intensity.
Measured: 6 hours, 24 hours, 48 hours, 72 hours, 1 week, 1 month after root canal treatment.
Clinical Success and Radiographic Radiographic Changes in Periapical Lesion Size Following Root Canal Treatment
Radiographic assessment of periapical lesion size following single-session primary root canal treatment. Periapical lesion size will be measured on digital periapical radiographs using image analysis software. A coin of known diameter will be used as a radiographic calibration reference to standardize measurements. The maximum diameter of the periapical radiolucency will be measured in millimeters (mm) at each follow-up examination (1, 3, 6, and 12 months). Changes in lesion size will be calculated by comparing measurements obtained at baseline and subsequent follow-up examinations.
Measured: 1 months / 3 months /6 months / 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start22 Apr 2025
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Single-visitStudies 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, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelda Erdem Hepşenoğlu, Istanbul Medipol University Hospital
- Investigators
- Tan Firat eyuboglu, Prof, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868315
- Sponsor's protocol ID
- E-10840098-202.3.02-3256
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After its publication in a journal, the investigators want to share their data.
Publications
Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.
PubMed 3457698Schilder H. Filling root canals in three dimensions. 1967. J Endod. 2006 Apr;32(4):281-90. doi: 10.1016/j.joen.2006.02.007. No abstract available.
PubMed 16554195Wu MK, Bud MG, Wesselink PR. The quality of single cone and laterally compacted gutta-percha fillings in small and curved root canals as evidenced by bidirectional radiographs and fluid transport measurements. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):946-51. doi: 10.1016/j.tripleo.2009.07.046. Epub 2009 Oct 28.
PubMed 19875314Raman V, Camilleri J. Characterization and Assessment of Physical Properties of 3 Single Syringe Hydraulic Cement-based Sealers. J Endod. 2024 Mar;50(3):381-388. doi: 10.1016/j.joen.2024.01.001. Epub 2024 Jan 14.
PubMed 38219956Candeiro GT, Correia FC, Duarte MA, Ribeiro-Siqueira DC, Gavini G. Evaluation of radiopacity, pH, release of calcium ions, and flow of a bioceramic root canal sealer. J Endod. 2012 Jun;38(6):842-5. doi: 10.1016/j.joen.2012.02.029. Epub 2012 Apr 4.
PubMed 22595123Guven EP, Tasli PN, Yalvac ME, Sofiev N, Kayahan MB, Sahin F. In vitro comparison of induction capacity and biomineralization ability of mineral trioxide aggregate and a bioceramic root canal sealer. Int Endod J. 2013 Dec;46(12):1173-82. doi: 10.1111/iej.12115. Epub 2013 Apr 26.
PubMed 23617276Veljovic D, Colic M, Kojic V, Bogdanovic G, Kojic Z, Banjac A, Palcevskis E, Petrovic R, Janackovic D. The effect of grain size on the biocompatibility, cell-materials interface, and mechanical properties of microwave-sintered bioceramics. J Biomed Mater Res A. 2012 Nov;100(11):3059-70. doi: 10.1002/jbm.a.34225. Epub 2012 Jun 26.
PubMed 22733649Jo SB, Kim HK, Lee HN, Kim YJ, Dev Patel K, Campbell Knowles J, Lee JH, Song M. Physical Properties and Biofunctionalities of Bioactive Root Canal Sealers In Vitro. Nanomaterials (Basel). 2020 Sep 4;10(9):1750. doi: 10.3390/nano10091750.
PubMed 32899641Camargo RV, Silva-Sousa YTC, Rosa RPFD, Mazzi-Chaves JF, Lopes FC, Steier L, Sousa-Neto MD. Evaluation of the physicochemical properties of silicone- and epoxy resin-based root canal sealers. Braz Oral Res. 2017 Aug 21;31:e72. doi: 10.1590/1807-3107BOR-2017.vol31.0072.
PubMed 28832718Sathorn C, Parashos P, Messer HH. Effectiveness of single- versus multiple-visit endodontic treatment of teeth with apical periodontitis: a systematic review and meta-analysis. Int Endod J. 2005 Jun;38(6):347-55. doi: 10.1111/j.1365-2591.2005.00955.x.
PubMed 15910469Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.
PubMed 17931388Karamifar K, Tondari A, Saghiri MA. Endodontic Periapical Lesion: An Overview on the Etiology, Diagnosis and Current Treatment Modalities. Eur Endod J. 2020 Jul 14;5(2):54-67. doi: 10.14744/eej.2020.42714. eCollection 2020.
PubMed 32766513
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
- ClinicalTrials.gov ID
- NCT07868315
- Acronym / sponsor ID
- E-10840098-202.3.02-3256
- Conditions
- Single-visit, Periapical Periodontitis
- Keywords
- treatment outcome, periapical health, post operative pain, periapical index, Chronic apical periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2027 (estimated)
- First posted
- 9 Oct 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 study evaluates the postoperative pain and long-term clinical and radiographic success of single-visit primary root canal treatment in asymptomatic teeth with periapical lesions.
Detailed description
A total of 200 patients will be evaluated and divided into four treatment groups according to the root canal filling material and technique: AH Plus with warm gutta-percha, AH Plus with the single-cone technique, TotalFill BC Sealer with the single-cone technique, and One-Fil with the single-cone technique. Postoperative pain will be assessed, while periapical healing will be evaluated clinically and radiographically using the Periapical Index (PAI) during follow-up visits extending from 1 month to 1 year. The study aims to compare different root canal sealers and obturation techniques and contribute to the understanding of their long-term treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One Fill | Experimental | Other: One-FillRoot canal obturation using One Fill root canal sealer according to the manufacturer's instructions. |
| TotalFill | Experimental | Other: TotalFillRoot canal obturation using TotalFill root canal sealer according to the manufacturer's instructions. |
| AH Plus + Single Cone | Experimental | Other: AH Plus + Single ConeRoot canal obturation using AH Plus root canal sealer in combination with a single-cone obturation technique. |
| AH Plus + Continuous Wave | Experimental | Other: AH Plus + Continuous WaveRoot canal obturation using AH Plus root canal sealer in combination with a continuous-wave obturation technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-65 years.
- Patients classified as ASA Physical Status I or II according to the American Society of Anesthesiologists (ASA) classification:
- Teeth that have not previously undergone root canal retreatment or surgical intervention.
- Patients who are able to read and sign the informed consent form.
- Patients who are physically and mentally able to tolerate the planned dental treatment.
Key exclusion criteria (8 listed)
- Pregnant or lactating women.
- Patients with chronic periodontal disease and/or a periodontal probing depth >4 mm.
- Symptomatic patients.
- Patients who are unable to comply with the scheduled follow-up periods.
- Patients who have used analgesics within 1 week or antibiotics within 1 month prior to 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 |
|---|---|---|
| One-FillRoot canal obturation using One-Fill bioceramic sealer with a single-cone technique. The prepared root canal is filled with a fitted gutta-percha cone coated with One-Fill sealer according to the manufacturer's instructions. | Other | One Fill |
| TotalFillRoot canal obturation using TotalFill BC Sealer with a single-cone technique. The prepared root canal is filled with a fitted gutta-percha cone coated with TotalFill BC Sealer according to the manufacturer's instructions. | Other | TotalFill |
| AH Plus + Single ConeRoot canal obturation using AH Plus epoxy resin-based sealer with a single-cone technique. A fitted gutta-percha cone is coated with AH Plus sealer and placed to the working length according to the study protocol. | Other | AH Plus + Single Cone |
| AH Plus + Continuous WaveRoot canal obturation using AH Plus epoxy resin-based sealer with the continuous wave of condensation technique. The master gutta-percha cone is fitted to the working length, followed by down-pack and backfill procedures using heated gutta-percha according to the study protocol. | Other | AH Plus + Continuous Wave |
Primary outcome
Postoperative Pain
Time frame: 6 hours, 24 hours, 48 hours, 72 hours, 1 week, 1 month after root canal treatment.
Postoperative pain following single-session primary root canal treatment, assessed using a 10-point visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. higher scores indicate greater pain intensity.
Clinical Success and Radiographic Radiographic Changes in Periapical Lesion Size Following Root Canal Treatment
Time frame: 1 months / 3 months /6 months / 12 months
Radiographic assessment of periapical lesion size following single-session primary root canal treatment. Periapical lesion size will be measured on digital periapical radiographs using image analysis software. A coin of known diameter will be used as a radiographic calibration reference to standardize measurements. The maximum diameter of the periapical radiolucency will be measured in millimeters (mm) at each follow-up examination (1, 3, 6, and 12 months). Changes in lesion size will be calculated by comparing measurements obtained at baseline and subsequent follow-up examinations.
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 9 Oct 2026.
- Results publication: PubMed 3457698Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.
- Results publication: PubMed 16554195Schilder H. Filling root canals in three dimensions. 1967. J Endod. 2006 Apr;32(4):281-90. doi: 10.1016/j.joen.2006.02.007. No abstract available.
- Results publication: PubMed 19875314Wu MK, Bud MG, Wesselink PR. The quality of single cone and laterally compacted gutta-percha fillings in small and curved root canals as evidenced by bidirectional radiographs and fluid transport measurements. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Dec;108(6):946-51. doi: 10.1016/j.tripleo.2009.07.046. Epub 2009 Oct 28.
- Results publication: PubMed 38219956Raman V, Camilleri J. Characterization and Assessment of Physical Properties of 3 Single Syringe Hydraulic Cement-based Sealers. J Endod. 2024 Mar;50(3):381-388. doi: 10.1016/j.joen.2024.01.001. Epub 2024 Jan 14.
- Results publication: PubMed 22595123Candeiro GT, Correia FC, Duarte MA, Ribeiro-Siqueira DC, Gavini G. Evaluation of radiopacity, pH, release of calcium ions, and flow of a bioceramic root canal sealer. J Endod. 2012 Jun;38(6):842-5. doi: 10.1016/j.joen.2012.02.029. Epub 2012 Apr 4.
- Results publication: PubMed 23617276Guven EP, Tasli PN, Yalvac ME, Sofiev N, Kayahan MB, Sahin F. In vitro comparison of induction capacity and biomineralization ability of mineral trioxide aggregate and a bioceramic root canal sealer. Int Endod J. 2013 Dec;46(12):1173-82. doi: 10.1111/iej.12115. Epub 2013 Apr 26.
- Results publication: PubMed 22733649Veljovic D, Colic M, Kojic V, Bogdanovic G, Kojic Z, Banjac A, Palcevskis E, Petrovic R, Janackovic D. The effect of grain size on the biocompatibility, cell-materials interface, and mechanical properties of microwave-sintered bioceramics. J Biomed Mater Res A. 2012 Nov;100(11):3059-70. doi: 10.1002/jbm.a.34225. Epub 2012 Jun 26.
- Results publication: PubMed 32899641Jo SB, Kim HK, Lee HN, Kim YJ, Dev Patel K, Campbell Knowles J, Lee JH, Song M. Physical Properties and Biofunctionalities of Bioactive Root Canal Sealers In Vitro. Nanomaterials (Basel). 2020 Sep 4;10(9):1750. doi: 10.3390/nano10091750.
- Results publication: PubMed 28832718Camargo RV, Silva-Sousa YTC, Rosa RPFD, Mazzi-Chaves JF, Lopes FC, Steier L, Sousa-Neto MD. Evaluation of the physicochemical properties of silicone- and epoxy resin-based root canal sealers. Braz Oral Res. 2017 Aug 21;31:e72. doi: 10.1590/1807-3107BOR-2017.vol31.0072.
- Results publication: PubMed 15910469Sathorn C, Parashos P, Messer HH. Effectiveness of single- versus multiple-visit endodontic treatment of teeth with apical periodontitis: a systematic review and meta-analysis. Int Endod J. 2005 Jun;38(6):347-55. doi: 10.1111/j.1365-2591.2005.00955.x.
- Results publication: PubMed 17931388Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.
- Results publication: PubMed 32766513Karamifar K, Tondari A, Saghiri MA. Endodontic Periapical Lesion: An Overview on the Etiology, Diagnosis and Current Treatment Modalities. Eur Endod J. 2020 Jul 14;5(2):54-67. doi: 10.14744/eej.2020.42714. eCollection 2020.
- Individual participant dataSharing planned: Yes. After its publication in a journal, the investigators want to share their data.
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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.
Tan Firat eyuboglu, Prof study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-Fill, TotalFill and AH Plus + Single Cone in people with Single-visit and Periapical Periodontitis, run by Istanbul Medipol University Hospital 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 8 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: looking for participants now, as of the sponsor's last update on 9 Oct 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?
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?
Contact omer albanki, DDS (00905365927496, omaralbanki1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 6 hours, 24 hours, 48 hours, 72 hours, 1 week, 1 month after root canal treatment.). 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 NCT07868315, which also lists 12 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 9 Oct 2026.