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Root Canal ObturationNCT07307807

Evaluation of Postoperative Pain and Lesion Healing in Periapical Lesion-Affected Teeth Obturated With Different Root Canal Sealers

A study testing AH Plus and PAI 2-3, AH Plus and PAI 4 and TotalFill BC Sealer and PAI 2-3 in people with Root Canal Obturation and Apical Periodontitis, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The root canal treatment of volunteers with asymptomatic apical periodontitis will be completed using TotalFill BC and AH Plus root canal sealers, and postoperative pain as well as healing will be comparatively evaluated through radiographic follow-ups at predetermined time intervals. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Root Canal Obturation, Apical Periodontitis
What is being tested?
AH Plus and PAI 2-3, AH Plus and PAI 4 and TotalFill BC Sealer and PAI 2-3
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2025to 1 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthy individuals aged between 18 and 60 years with no systemic diseases
  • Teeth with periapical lesions (apical periodontitis) that have not undergone previous root canal treatment
  • Single-rooted maxillary and mandibular teeth
  • Teeth with PAI scores of 2, 3, and 4 according to the PAI classification
  • Teeth without a sinus tract or acute apical abscess
  • Patients who voluntarily agree to participate in the study and attend follow-up visits
  • Teeth with sufficient remaining tooth structure to allow restoration with a direct restoration after root canal treatment -

Who cannot join

  • Patients who have used antibiotics, analgesics, or anti-inflammatory drugs within the last 7 days
  • Pregnant or breastfeeding patients
  • Patients with traumatic malocclusion
  • Patients without occlusal contact
  • Teeth with root resorption, open apices, or calcification
  • Teeth presenting gingival recession greater than 3 mm, deep periodontal pockets, or mobility
Show all 16Show fewer
  • Teeth with root fractures or cracks
  • Presence of an adjacent tooth requiring endodontic treatment that may cause referred pain
  • Multirooted teeth
  • Teeth with a PAI score of 5
  • Teeth requiring restorations such as endocrowns, onlays, overlays, or full crowns due to excessive loss of tooth structure after root canal treatment
  • Teeth with structural loss severe enough to require post-core application
  • Cases in which adequate anesthesia cannot be achieved with local anesthesia alone (requiring additional intrapulpal or intraligamentary anesthesia)
  • Teeth requiring active periodontal treatment
  • Individuals with severe systemic diseases
  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Yıldırım Beyazıt University

    Ankara, Keçiören, 06490

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Postoperative Pain and Lesion Healing in Periapical Lesion-Affected Teeth Obturated With Different Root Canal Sealers: Prospective Study

The root canal treatment of volunteers with asymptomatic apical periodontitis will be completed using TotalFill BC and AH Plus root canal sealers, and postoperative pain as well as healing will be comparatively evaluated through radiographic follow-ups at predetermined time intervals.

Read the detailed description

The study is planned as a randomized controlled clinical trial. The randomized controlled study will be conducted at the Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Endodontics, and will include adult volunteers who have been diagnosed with asymptomatic apical periodontitis, present periapical lesions with PAI scores of 2, 3, and 4, have an indication for root canal treatment, meet the inclusion criteria of the study, and have provided written informed consent.

Volunteers will be randomly selected from patients attending our clinic according to lesion size. A computer-assisted randomization method (www.randomizer.org) will be used. Root canal treatments will be completed using AH Plus or TotalFill BC root canal sealers.

The required sample size will consist of a total of 64 volunteers: 16 volunteers with PAI 2-3 scored teeth treated with AH Plus, 16 volunteers with PAI 4 scored teeth treated with AH Plus, 16 volunteers with PAI 2-3 scored teeth treated with TotalFill BC, and 16 volunteers with PAI 4 scored teeth treated with TotalFill BC.

After completion of the root canal treatments, postoperative radiographs will be obtained and follow-up will be performed at 6 months. Postoperative pain will be assessed at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as at 1 week following completion of the root canal treatment.

Being tested
AH Plus and PAI 2-3, AH Plus and PAI 4, TotalFill BC Sealer and PAI 2-3, TotalFill BC Sealer and PAI 4
Keywords
AH Plus, TotalFill BC Sealer, Postoperative pain, Fractal analysis, Visual Analog Scale (VAS)
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.

  • AH Plus and PAI 2-3Procedure or surgery

    The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.

    Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

  • AH Plus and PAI 4Procedure or surgery

    The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.

    Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.

    Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated

  • TotalFill BC Sealer and PAI 2-3Procedure or surgery

    The TotalFill BC root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.

    Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.

    Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

  • TotalFill BC Sealer and PAI 4Procedure or surgery

    The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings.

    Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records.

    Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

Study groups in NCT07307807
Study groupRoleWhat they receive
AH Plus and PAI 2-3ExperimentalTeeth with PAI scores of 2 and 3 that were obturated with AH Plus and completed in a single visit.
Receives: Procedure: AH Plus and PAI 2-3
AH Plus and PAI 4ExperimentalTeeth with a PAI score of 4 that were obturated with AH Plus and completed in a single visit.
Receives: Procedure: AH Plus and PAI 4
TotalFill BC Sealer and PAI 2-3ExperimentalTeeth with PAI scores of 2 and 3 obturated with TotalFill BC and completed in a single visit.
Receives: Procedure: TotalFill BC Sealer and PAI 2-3
TotalFill BC Sealer and PAI 4ExperimentalTeeth with a PAI score of 4 obturated with TotalFill BC and completed in a single visit.
Receives: Procedure: TotalFill BC Sealer and PAI 4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fractal analysis

    In this study, fractal analysis of each sample will be performed using the box-counting method.

    Measured: 6. month

  2. VAS scala

    Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, on a form using the Visual Analog Scale (VAS). One week after treatment, volunteers will be contacted by telephone, and the pain scores indicated on the pain assessment forms will be obtained and recorded in the patient files.

    Measured: 6.,12.,24.,36.,48.,72. hours and 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start1 Jun 2025
  3. Primary completion1 Aug 2025
  4. Study completion1 Jan 2026 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07307807
Sponsor's protocol ID
2025/14-03(KA-25010)
Status last verified
Dec 2025
First submitted
15 Dec 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hegde VR, Hegde SR, Fanibunda UE, Vartak MA. Comparative evaluation of postoperative pain and healing following root canal obturation with calcium silicate and bioactive glass-based sealers to epoxy resin-based sealers: A systematic review and meta-analysis. J Conserv Dent Endod. 2025 Mar;28(3):211-221. doi: 10.4103/JCDE.JCDE_8_25. Epub 2025 Mar 3.

    PubMed 40256693
  • Gotler M, Bar-Gil B, Ashkenazi M. Postoperative pain after root canal treatment: a prospective cohort study. Int J Dent. 2012;2012:310467. doi: 10.1155/2012/310467. Epub 2012 Mar 15.

    PubMed 22505897
  • de Oliveira CB, Rocha TG, Pintor AVB, Magno MB, Abrahao AC, Maia LC, Romanach MJ, Visconti MA. Using fractal analysis to assess periapical bone formation after endodontic treatment: A systematic review and meta-analysis. Imaging Sci Dent. 2025 Jun;55(2):126-138. doi: 10.5624/isd.20240221. Epub 2025 Apr 10.

    PubMed 40607066
  • Cosar M, Kandemir Demirci G, Caliskan MK. The effect of two different root canal sealers on treatment outcome and post-obturation pain in single-visit root canal treatment: A prospective randomized clinical trial. Int Endod J. 2023 Mar;56(3):318-330. doi: 10.1111/iej.13870. Epub 2022 Nov 22.

    PubMed 36385378
  • Tan HSG, Lim KC, Lui JN, Lai WMC, Yu VSH. Postobturation Pain Associated with Tricalcium Silicate and Resin-based Sealer Techniques: A Randomized Clinical Trial. J Endod. 2021 Feb;47(2):169-177. doi: 10.1016/j.joen.2020.10.013. Epub 2020 Oct 22.

    PubMed 33098889

Questions about this trial

What is this clinical trial studying?

A study testing AH Plus and PAI 2-3, AH Plus and PAI 4 and TotalFill BC Sealer and PAI 2-3 in people with Root Canal Obturation and Apical Periodontitis, run by Ankara Yildirim Beyazıt 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 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fractal analysis (time frame: 6. month). 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 NCT07307807, which also lists 5 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 29 Dec 2025.

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