Effect of Thickness Variation in Coronal Plug on Root Maturation and Periapical Healing

NCT07123597 | Completed DMC

• 1 other identifier: Regenerative Endodontics
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

d. Second visit: After 3 weeks the patients will be randomly divided into 2 groups: Group A: Patients will be anesthetized 1 carpule of mepivacaine without vasoconstrictor (Mepivacaine HCl 3%), the access will be reopened under rubber dam isolation and the canal will be irrigated with a total of 20 ml of 1.5-2.5% sodium hypochlorite solution. The canal will then be dried with sterile paper points; a sterile sharp needle will be used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process. Over a 15-minute time period, the blood will be allowed to clot to a level of 3 mm below the cemento-enamel junction. A resorbable matrix such as CollaPlug™, Collacote™, CollaTape™ will be placed over the blood clot if necessary. Then 3 mm of MTA will be placed using a suitable size amalgam carrier. A damped cotton pellet on a tweezer placed above the unset MTA and large condenser will be used to seal the canal orifice completely. The access cavity will be sealed with Fuji IX glass ionomer filling material and acid etched composite resin bonded filling material. Group B: The same procedures that will be followed in group A will be also done in group B, except for the thickness of MTA coronal plug which will be 5mm in its thickness e. Follow-up: The patients will be recalled after 1, 6 and 12 months for follow up. The post-treatment follow-up examination will be accomplished as follows:

• CBCT scan will be done at 6 and 12 months follow up appointments.
• An evaluation was performed on each patient to assess presence of any signs and symptoms clinically by inspection, percussion, palpation, or biting on the treated tooth.

Conditions

Immature Permanent Teeth With Open Apex

Keywords

regenerative endodontics; root maturation; periapical healing

Outcome Measures

Primary Outcomes (1)

• Root maturation

  after superimposition of the pre and post operative CBCT percentage growth of the root was calculated after 1. measuring the root length in millimeter in the pre and post operative CBCT increase in length = (follow up length - base line length). 2. Amount of radiographic increase in the root dentinal wall thickness Dentin thickness in the post operative CBCT = (root thickness-pulp space) and was compared to the baseline CBCT radiograph. The increase in thickness was calculated as follows: increase in thickness = (follow-up thickness -base line thickness). 3. measuring the decrease of apical diameter: Using the preset measurement scale, the diameter of the apical foramen was measured in millimeters on the 12 months follow up CBCT radiograph and was compared to the baseline CBCT radiograph (decrease of apical diameter = follow-up apical diameter-base line apical diameter).

  after 12 month

Secondary Outcomes (1)

• periapical healing

  12 month

Study Arms (2)

Group A

EXPERIMENTAL

Group A: Teeth will be treated by regenerative endodontic procedures with placing of 5mm coronal plug.

Other: 5mm bioceramic putty coronal plug

Group B

EXPERIMENTAL

Group B: Teeth will be treated by regenerative endodontic procedures with placing of 3mm coronal plug.

Other: 3mm bioceramic putty coronal plug

Interventions

5mm bioceramic putty coronal plug OTHER

Teeth will be treated by regenerative endodontic procedures with placing of 5mm bioceramic putty coronal plug.

Group A

3mm bioceramic putty coronal plug OTHER

Teeth will be treated by regenerative endodontic procedures with placing of 3mm bioceramic putty coronal plug.

Group B

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients were medically free \[American Society of Anesthesiologists (ASA) Class I or II\].
• Age ranging between 10-18 years old.
• No sex predilection.
• Patients having asymptomatic and/or symptomatic immature necrotic anterior teeth.

You may not qualify if:

• Patients with a history of allergy to any of the material used in the study.
• Patients with systemic diseases (e.g. diabetes mellitus, bleeding disorders, heart diseases, liver diseases, kidney diseases, genetic disorders and syndromes).
• Psychologically disturbed patients.
• Teeth that needed a post and core as the final restoration.
• Patients who had teeth with periodontal pockets more than 3 mm or generalized chronic periodontitis
• Teeth with developmental anomalies (i.e., dens invaginatus or a palatogingival groove)
• Patients who had radiographic evidence of external / internal root resorption or cystic lesion.
• Patients refused participating in the study.

Sponsors & Collaborators

• Rania ElSayed Soliman: lead
• Benha National University: collaborator

Study Sites (1)

Benha National University

Cairo, 4470351, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: July 3, 2022
• Primary Completion: June 6, 2023
• Study Completion: June 30, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)