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

NCT07679152 | Completed

• 1 other identifier: FDASU-RECM012384
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Regenerative Endodontic Procedures; Irreversible Pulpitis

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (3)

Conventional root canal treatment

ACTIVE COMPARATOR

Procedure: Conventional root canal treatment

Regeneration group

ACTIVE COMPARATOR

Procedure: Regenerative Endodontics procedures

Cleaning and Shaping only

ACTIVE COMPARATOR

Procedure: Cleaning and Shaping Only and coronal seal

Interventions

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.

Regeneration group

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.

Cleaning and Shaping only

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.

Conventional root canal treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 1, 2026
• Study Start: October 8, 2024
• Primary Completion: May 14, 2026
• Study Completion: May 20, 2026
• Last Updated: July 1, 2026

Record last verified: 2023-02

Locations

EG (1)