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

December 7, 2021 updated by: Rana sharaf, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Turmeric
Turmeric extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol
Procedure: Pulpotomy
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.
EXPERIMENTAL: Thymus Vulgaris
Thymus Vulgaris extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol
Procedure: Pulpotomy
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.
EXPERIMENTAL: Nigella Sativa
Nigella Sativa extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol
Procedure: Pulpotomy
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.
EXPERIMENTAL: Aloe Vera
Aloe Vera extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol
Procedure: Pulpotomy
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.
ACTIVE_COMPARATOR: Formocresol
Formocresol will be used as a dental pulp dressing material after pulpotomy to be compared with other materials.
Procedure: Pulpotomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 to 6 months
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
1 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Noha S Kabil, PHD, Professor
  • Study Director: Basma G Awad, PHD, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

November 1, 2021

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

January 17, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED19-3D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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