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Completed

NCT Number: NCT04719247

Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth

when caries reaches the pulp of the tooth, it has to be removed and replaced with a material. In this study im examining the clinical and radiographic signs and symptoms after using different natural materials in pulpotomized molars and compared to the formocresol.

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Key information

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

Patients who have irreversible pulpitis and need pulpotomy will be selected randomly from the out patient clinic. they will be assigned randomly to different study and control groups. pulpotomy will be performed in the second primary molar and 1 of the five materials will be put in the pulp chamber (aloe vera, nigella sativa, thymus vulgaris, turmeric and formocresol). It will be covered with a restoration and a stainless steel crown. Patients follow up will be done after 1,3,6 and 12 months to assess clinical and radiographic signs and symptoms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged from 4 to 7 years old
  • Patients who are medically free
  • Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy.
  • No clinical signs or symptoms as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling.
  • No radiographic signs of any periapical pathosis or signs of internal or external root resorption.

Exclusion criteria

  • Patients who have any medical condition.
  • Teeth that are badly broken down, that cannot be restored.
  • Presence of uncontrolled bleeding.
  • Clinical evidence of non-vitality such as presence of an abscess or a sinus or premature mobility.
  • Radiographic evidence of bone resorption, internal or external root resorption and periapical or interradicular radiolucency.

Treatment and study plan

Pulpotomy

Procedure

Irreversibly damaged dental pulp is partially removed and a dressing either Turmeric or Thymus Vulgaris or Nigella Sativa or Aloe Vera is placed. Clinical and Radiographic signs and symptoms are assessed and compared with Formocresol.

Primary outcomes

  1. Clinical signs and symptoms of pulp reaction

    Time frame: 1 to 6 months

    Evaluated using Zurn and Seale criteria. (pain, infection, gingival health, tooth mobility) where 1 indicates asymptomatic and 4 indicates severe discomfort

  2. Radiographic signs of pulp reaction

    Time frame: 1 to 6 months

    Evaluated using Zurn and Seale criteria. (radiolucency, bone resorption, internal or external resorption) where 1 indicates no radiographic changes while 4 indicates the presence of pathologic changes

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth" A Randomized Controlled Study

Acronym: RCT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Dec 15, 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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