NCT07123597

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

Completed NA Last updated 29 August 2025

What this trial tests

NA trial testing 5mm bioceramic putty coronal plug in Immature Permanent Teeth With Open Apex in 18 participants. Completed in 30 June 2024.

Timeline

3 July 2022

Primary endpoint
6 June 2023

30 June 2024

Quick facts

Lead sponsor	Rania ElSayed Soliman
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	18
Start date	3 July 2022
Primary completion	6 June 2023
Estimated completion	30 June 2024
Sites	1 location across Egypt

Drugs / interventions tested

• 5mm bioceramic putty coronal plug
• 3mm bioceramic putty coronal plug

Conditions studied

• Immature Permanent Teeth With Open Apex — all drugs for Immature Permanent Teeth With Open Apex →

Sponsor

Rania ElSayed Soliman

Who can join

Adults 10 to 18, any sex, with Immature Permanent Teeth With Open Apex. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.