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Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions

Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions: A Randomized Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07785973
Enrollment
30
Registered
2026-08-25
Start date
2026-08-01
Completion date
2027-08-10
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Brief summary

Tissue repair is an essential process that reestablishes tissue integrity and regular function. Nevertheless, different therapeutic factors and clinical conditions may interfere in this process of periapical healing.The success of root canal treatment is affected by the correct choice of clinical protocol. These factors are dependent on the sanitization process (instrumentation, irrigating solution, irrigating strategies, and intracanal dressing) the apical limit of the root canal preparation and obturation, and the quality of the sealer. The challenges affecting the healing process of endodontically treated teeth include control of the inflammation of pulp or infectious processes and simultaneous neutralization of unpredictable provocations to the periapical tissue.

Detailed description

The goal of root canal obturation is to obtain complete sealing to hinder the communication between the root canal and the periapical tissue. This favors the process of apical and periapical repair after endodontic therapy.An ideal root canal sealer must have adequate physical, chemical, and biological properties. Several factors can affect the success of RCT, including the type and composition of sealer utilized. The presence and release of substances from the sealers can cause different reactions when in contact with tissue. AH Plus, an epoxy resin-based sealer, is considered the gold standard among root canal sealers due to its excellent physical, chemical, and biological properties. However, the biocompatibility of this sealer remains a subject of debate, as some studies raise concerns about potential inflammatory responses or cytotoxic effects associated with resin-based sealers. Recent advancements have introduced bioceramic-based sealer composed of zirconium oxide, calcium silicates, calcium phosphates, and calcium hydroxide. This sealer is available in pre-mixed syringes for easy application and exhibit hydrophilic properties, allowing for setting reactions in a moist environment within the root canal, thus preventing shrinkage. Moreover, bioceramic-based sealers exhibit favorable biocompatibility due to their similarity to dentin and ability to stimulate mineralization. NeoSealer Flo (NeoFlo, NuSmile, Houston, TX, USA) is a ready-to-use bioceramic root canal sealer. According to the manufacturer, it has hydroxyapatite formation ability, biocompatibility, dimensional stability, and antimicrobial activity. NeoFlo has adequate physicochemical properties and releases biologically active ions, such as calcium and phosphate. The addition of cetrimide to NeoSealer Flo promoted a greater inflammatory reaction, but the reduction of inflammatory cells and rearrangement of connective tissue suggests that NeoSealer Flo and the associations with cetrimide are biocompatible and have bioactive potential. Endodontic treatment comprises the overall management of pre-, intra- and post-operative symptoms, including post-operative endodontic pain, considered as a complication susceptible to chronicization. Post-operative pain is very common and highly unpreventable and has a multifactorial etiology and a potential pathogenic link to the acute inflammation of the periapical area, secondary to localized chemical, mechanical, host and/or microbial damage occurring during endodontic treatment.

Interventions

to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers: * NeoSEALER Flo * AH plus Resin sealer

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with mature permanent teeth. * Patients with apical periodontitis. * Maxillary anterior teeth only will be involved. * Patients should be free from any systemic disease that may affect normal healing and predictable outcome. * Patients who will agree to the consent and will commit to follow-up period. * The selected teeth should have periapical lesion score ≤3

Exclusion criteria

* Patients with immature canals. * Patients with swelling. * Pregnant females. * Patients who could/would not participate in a 1-year follow-up. * Geriatric patients. * Patients with old age. * Teeth with periodontal involvement. * Teeth with vertical root fractures. * Non-restorable teeth. * cases with previously initiated endodontic treatment.

Design outcomes

Primary

MeasureTime frameDescription
Treatment of Postoperative Painfrom 0 hours to 2 weeks after the procedurePatients will be evaluated for postoperative pain via (NRS) to record the intensity of pain.as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain".

Secondary

MeasureTime frameDescription
Periapical HealingAfter 6 months to 12 monthsPeriapical healing will be evaluated by comparing the size of the initial lesion pre-operatively and postoperatively (after 6 and 12 months), using periapical radiographs and CBCT. This will be aggregated in percentage (%).

Countries

Egypt

Contacts

CONTACTAllaa Mohamed Kamel Mohamed, MSC
allaa91mk@gmail.com+201006767773
CONTACTMaged Mohamed Negm, professor
drmagednegm@gmail.com
STUDY_CHAIRMaged Mohamed Negm, M.D

Professor of Endodontics, Faculty of Dentistry,Cairo University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026