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OpenTrials
Completed

NCT Number: NCT05098483

Regenerative Endodontics for Non-vital Primary Molars

Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold

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Key information

Conditions

Pulp and Periapical Tissue Disease

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mai Mahmoud Hasaballah

Giza, 11865, Egypt

About this study

Non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups:

Group 1: conventional root canal treatment Group 2: Regenerative endodontic treatment using MTA Group3: Regenerative endodontic treatment using Biodentine Each group will be followed up for 12 months

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-vital mandibular primary second molar.
  • Restorable tooth

Exclusion criteria

  • Patients allergic to medicaments or antibiotics necessary to complete the procedure.
  • Special Health Care Needs
  • Excessive mobility
  • Presence of internal or external root resorption.

Treatment and study plan

Regeneration in primary molars by using MTA

Procedure

Regenerative endodontic procedure in nonvital primary molars using MTA capping material

Regeneration in primary molars by using biodentine

Procedure

Regenerative endodontic treatment in primary molars with biodentine as capping material

Conventional Root canal treatment in primary molars

Procedure

Removal of pulp tissue from the canals of primary molars

Primary outcomes

  1. Clinical measures

    Time frame: 12 months

    39 children with no pain or swelling (i.e) successful outcomes

  2. Radiographic measures

    Time frame: 12 months

    39 children with no furcal radiolucency or presence of internal resorption. (i.e) successful outcome

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Regenerative Endodontics Using MTA and Biodentine for Non-vital Primary Molars Compared to Conventional Root Canal Treatment. (A Randomized Controlled Clinical Trial)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2021
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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