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

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

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.

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis; Regenerative Endodontic Procedures
• Intervention / Treatment: Procedure: Conventional root canal treatment; Procedure: Regenerative Endodontics procedures; Procedure: Cleaning and Shaping Only and coronal seal

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional root canal treatment	Procedure: Conventional root canal treatment; 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.
Active Comparator: Regeneration group	Procedure: Regenerative Endodontics procedures; 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.
Active Comparator: Cleaning and Shaping only	Procedure: Cleaning and Shaping Only and coronal seal; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Absence of periapical pathosis. (Periapical status in a conventional 2D periapical radiograph) (Periapical index PAI)	12 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Actual): May 14, 2026
• Study Completion (Actual): May 20, 2026

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FDASU-RECM012384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No