Skip to main content
OpenTrials
Completed

NCT Number: NCT05181813

Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols

This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Teeth Dental Pulp Diseases Dental Pulp Necrosis Infected Pulp Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pulp Necroses Root Canal Treatment Stomatognathic Diseases Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary teeth with infected necrotic pulp clinically and radiographically

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The cooperation of the child and parents, during the treatment plan, and the commitment to attend the follow-up appointments.
  • Parents signed the consent to participate in the study.
  • Absence of any systemic disease, which would contraindicate pulp therapy.
  • Child didn't have any history of a sensitive reaction to any component of used materials.
  • Present half to two third of tooth root or more
  • Root with signs or symptoms of infected necrotic pulp or chronic abscess, with or without sinus tract, soft tissue swelling, mobility or tenderness to percussion, and internal or external root resorption or unsuccessful past pulp treatment.

Exclusion criteria

All that does not correspond to inclusion criteria.

Treatment and study plan

Ginge-Cal

Procedure

Fill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal)

Metapex

Procedure

Fill the infected root canal of of primary teeth with Metapex

Primary outcomes

  1. Percentage of primary teeth with control necrotic pulp by clinical examination

    Time frame: Up to 18 months

    The primary outcome was evaluated using clinical evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Clinical success will be judged to have occurred when there are no reports of pain, abscess, fistula, or mobility inconsistent with chronological age.

  2. Percentage of primary teeth with control necrotic pulp by radiographic examination

    Time frame: Up to 18 months

    The primary outcome was evaluated using Radiographic evaluation methods. Two pediatric dentists who are blind to treated teeth will conduct the clinical evaluation. A third examiner will be consulted if there is a disagreement between the results of the first two. Radiographic success will be evidenced by a decrease or absence of periapical or furcation area radiolucency and pathological root resorption

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Clinical Evaluation of Calcium Hydroxide Mixed With Gingerols Versus Metapex in Treatment of Primary Teeth With Infected Necrotic Pulp

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Jan 10, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.