Effect of Combined Root Canal Therapies in Mandibular Molars With Coexistent Mature and Immature Apices on the Healing Outcome

NCT07891611 | Completed

• 1 other identifier: 24/9/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Recent advancements in dentistry are driven by the development of dental materials and therapies that support tissue regeneration, including the application of bioactive, biocompatible calcium silicate-based materials like mineral trioxide aggregate (MTA), Biodentine, and bioceramic sealers/putties, which facilitated the integration of different treatment protocols. These root canal treatment protocols can be implemented in the same tooth based on the specific stage of root development, such as combining conventional root canal treatment in the root with a closed mature apex, and regeneration or apical plug in the root with an open immature apex, thereby gaining the benefits of each protocol with a minimally invasive, more conservative approach. No research studies have been published evaluating the effect of combined different root canal treatment protocols on the management of molars with coexistent mature and immature apices. This study will evaluate the outcomes of combined root canal therapies in mandibular molars with coexistent mature and immature apices.

Conditions

Periapical Diseases

Outcome Measures

Primary Outcomes (1)

• Periapical healing assessed by the Periapical Index (PAI)

  Periapical status of the treated tooth scored with the Periapical Index (PAI) on digital periapical radiographs at 3, 6 and 12 months, and on cone-beam computed tomography (CBCT) at 12 months. Lower scores indicate healthier periapical status. Reported as the number (%) of teeth in each PAI score category.

  Baseline, 3, 6 and 12 months after treatment

Secondary Outcomes (7)

• Tenderness to percussion

  3, 6 and 12 months after treatment

• Tenderness to palpation

  3, 6 and 12 months after treatment

• Presence of a sinus tract

  3 and 12 months after treatment

• Increased tooth mobility

  12 months after treatment

• Postoperative pain intensity

  24, 48, 72, 96 and 120 hours after treatment

Study Arms (2)

Apical plug group

EXPERIMENTAL

Mandibular molars with a mature mesial root and an immature distal root, treated in two visits: a bioceramic apical plug in the immature distal root and conventional root canal treatment in the mature mesial root.

Procedure: Bioceramic apical plug

Regeneration group

EXPERIMENTAL

Mandibular molars with a mature mesial root and an immature distal root, treated in two visits: a regenerative endodontic procedure in the immature distal root and conventional root canal treatment in the mature mesial root.

Procedure: Regenerative endodontic procedure

Interventions

Bioceramic apical plug PROCEDURE

Two-visit treatment of mandibular molars with a mature mesial root and an immature distal root. After chemomechanical preparation (ProTaper Next; 2.5% sodium hypochlorite (NaOCl); final irrigation with 1.5% NaOCl, saline and 17% ethylenediaminetetraacetic acid (EDTA) with sonic activation), a 3 to 4 millimeter (mm) apical plug of bioceramic putty (Bio-C Repair, Angelus) is placed in the immature distal root using the Micro-Apical Placement (MAP) One system. At the second visit, the mature mesial canals are obturated with gutta-percha and a bioceramic sealer (Bio-C Sealer) using warm vertical compaction, and the tooth is restored with composite resin.

Apical plug group

Regenerative endodontic procedure PROCEDURE

Two-visit treatment of mandibular molars with a mature mesial root and an immature distal root. Visit 1: gentle irrigation of the immature distal canal with 1.5% sodium hypochlorite (NaOCl) and saline, then calcium hydroxide intracanal medication (Metapaste) for 2 weeks. Visit 2 (local anesthesia without vasoconstrictor): irrigation with saline and 17% ethylenediaminetetraacetic acid (EDTA), bleeding induced with a precurved size 25 K-file about 2 millimeters (mm) beyond the apex to form an intracanal blood clot, then a coronal barrier of bioceramic putty placed with the Micro-Apical Placement (MAP) One system and covered with glass ionomer. The mature mesial canals are obturated with gutta-percha and a bioceramic sealer using warm vertical compaction, and the tooth is restored with composite resin.

Regeneration group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 6 to 16 years, of both sexes
• ASA physical status I or II (American Society of Anesthesiologists classification)
• Mandibular first or second permanent molar with non-vital (necrotic) pulp and two separate (non-fused) mesial and distal roots
• Mature mesial root: Cvek stage V root development, apical diameter equal to or less than K-file ISO size 40, Weine type III canal configuration
• Immature distal root: Cvek stage IV root development, apical diameter greater than K-file ISO size 40, Weine type I canal configuration
• Restorable tooth (Class I or II of the classification of teeth with extensive endodontic damage)
• Tooth mobility grade 0 or 1 (Miller classification)
• Periodontal probing depth 0 to 3.5 mm (Community Periodontal Index score 0 to 2)
• Periapical radiolucency 0 to 2 mm (Periapical Index score 0 to 2)
• Pre-operative pain score 0 to 5 on the modified Verbal Descriptor Scale

You may not qualify if:

• ASA physical status III or IV
• Uncooperative patients
• Teeth with fused roots, a single root, or more than two roots
• Teeth in which both the mesial and distal roots are mature, or both are immature

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine, Al-Azhar University (Boys, Cairo)

Cairo, Egypt

Location

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Mohamed Magdy Barakat, BDS

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2024
• Primary Completion: October 1, 2026
• Study Completion: October 1, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

EG (1)