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OpenTrials
Completed

NCT Number: NCT07679152

Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals

Statement of problem: Limitations and drawbacks associated with root canal obturation have the potential to impair periapical healing especially in the absence or delay of a proper coronal seal.

Aim of the study: Evaluate the endodontic treatment success in terms of resolution of signs and symptoms and periapical status using conventional periapical radiographs following two different treatment modalities, Coronally Sealed Non-obturated Canals, Regeneration-based Non-obturated Canals and comparing them to a control group of gutta percha obturated canals.

Materials and methods: Forty-eight Patients with mature, double canal, vital upper first premolars with irreversible pulpitis. In a single visit, the tooth is to be anesthetized, isolated and an access cavity is to be performed. Mechanical preparation of root canals is to be performed using the standardized technique reaching apical canal preparation to size #35 with taper of 4%. The patients will then be divided into three groups (n=16). Group One (Control group) will be conventionally obturated with gutta percha and resin sealer, and coronally sealed with glass ionomer and composite restoration. Group Two will be left unobturated and will receive a seal of MTA 2-3 mm below the CEJ then coronal restoration of glass ionomer and composite restoration. In Group Three, an induction of bleeding will be performed by apical violation and the tooth will receive a seal of MTA 2-3 mm below the CEJ then coronal seal of glass ionomer and composite restoration.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males.
  • Age: 18-50 years.
  • Medically free.
  • Vital, mature upper first premolars with irreversible pulpitis.
  • Adequate coronal tooth structure.
  • Compliant patients.

Exclusion criteria

  • Generalized periodontitis.
  • Females.
  • Vertical root fracture.
  • Immature teeth.
  • Necrotic teeth.
  • Systemic diseases that affect healing process.
  • Non restorable teeth.

Treatment and study plan

Regenerative Endodontics procedures

Procedure

The canals were be dried with paper points, and intentional over-instrumentation past the apical foramen into the periapical tissues was performed to induce bleeding inside the canal, to provide the blood clot that will act as a scaffold into which locally residing stem cells can get seeded and the cascade of healing process can initiate.

Cleaning and Shaping Only and coronal seal

Procedure

The canals were dried with paper points, left unobturated and received MTA coronal plug 2-3 mm below CEJ then sealed coronally with Glass ionomer filling and composite restoration.

Conventional Root Canal Treatment

Procedure

The canals were dried with paper points, obturated using gutta percha and resin sealer utilizing the warm vertical compaction obturation technique. The backfilling of the canal stopped at 3mm below canal orifice. Followed by an MTA coronal plus and glass ionomer and composite restoration.

Primary outcomes

  1. Resolution of signs and symptoms. (Clinical Assessment) (VAS)(Visual Analogue Scale) No pain on percussion or palpation, absence of swellings and sinus tracts.

    Time frame: 12 months

Secondary outcomes

  1. Absence of periapical pathosis. (Periapical status in a conventional 2D periapical radiograph) (Periapical index PAI)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals in Permanent Mature Vital Teeth

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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