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Completed

NCT Number: NCT04190914

Different Treatment Modality in Necrotic Primary Molars

Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.

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Key information

Conditions

Primary Teeth Dental Pulp Regeneration

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry- Ain Shams University

Cairo, Egypt

About this study

A convenient sample of preschool children have a necrotic primary second molar randomly allocated to one of the 3 study groups which are: group A (control) treated by the conventional treatment ( pulpectomy followed by stainless steel crown SSC), group B: treated by regeneration using triple antibiotic paste followed by SSC), group 3:(treated by regeneration using calcium hydroxide with iodoform(metapex) followed by SSC.

the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic success.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A child with one or more necrotic primary teeth
  • Presence of abscess/fistula
  • Sensitivity to percussion
  • Presence of maximum grade 2 mobility ( Not more than 1 mm)
  • Increases of the dental lamina dura
  • cooperative patients

Exclusion criteria

  • Medically compromised children
  • Patient allergic to any of the used materials
  • Presence of pathologic root resorption (internal-external) or more than 1/3 of the apical root.
  • Presence of vitality in the canals
  • Presence of grade 3 mobility
  • Non-restorable teeth

Treatment and study plan

pulp regeneration for necrotic primary teeth

Other

a pulp regeneration procedure will be applied for necrotic primary teeth with different intracanal medication compared to conventional pulpectomy used in treatment for necrotic primary teeth

Other names: different treatment options for necrotic primary teeth

Primary outcomes

  1. number of patients treated in the 3 groups and have a clinical success according to the checklist absence of pain, pain on percussion, mobility, clinical abscess or fistula

    Time frame: 12 months

    the blind outcome assessor will evaluate the clinical success at 6 and 12 years

  2. number of patients treated in the 3 groups and have a radio graphic success according to the checklist absence of radiolucency, internal or external root resorption

    Time frame: 12 months

    the blind outcome assessor will evaluate the radio graphic success at 6 and 12 years

Sponsors and collaborators

Lead sponsor

dina darwish

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Triple Antibiotic Paste and Calcium Hydroxide With Iodoform as Intra-canal Medications in Regenerative Treatment of Necrotic Primary Teeth Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2019
Registry last updated
Dec 17, 2021

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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