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

Ankara Yildirim Beyazıt University

Status: Active, not recruiting

Conditions: Apical Periodontitis; Root Canal Obturation

Treatments: Procedure: TotalFill BC Sealer and PAI 2-3; Procedure: AH Plus and PAI 4; Procedure: TotalFill BC Sealer and PAI 4; Procedure: AH Plus and PAI 2-3

Study type: Interventional

Funder types: Other

Identifiers

NCT07307807

2025/14-03(KA-25010)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

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

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 4 patient groups

AH Plus and PAI 2-3

Experimental group

Description:

Teeth with PAI scores of 2 and 3 that were obturated with AH Plus and completed in a single visit.

Treatment:

Procedure: AH Plus and PAI 2-3

AH Plus and PAI 4

Experimental group

Description:

Teeth with a PAI score of 4 that were obturated with AH Plus and completed in a single visit.

Treatment:

Procedure: AH Plus and PAI 4

TotalFill BC Sealer and PAI 2-3

Experimental group

Description:

Teeth with PAI scores of 2 and 3 obturated with TotalFill BC and completed in a single visit.

Treatment:

Procedure: TotalFill BC Sealer and PAI 2-3

TotalFill BC Sealer and PAI 4

Experimental group

Description:

Teeth with a PAI score of 4 obturated with TotalFill BC and completed in a single visit.

Treatment:

Procedure: TotalFill BC Sealer and PAI 4