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NCT04719247

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

NCT ID: NCT04719247

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Turmeric

Turmeric extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type 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.

Thymus Vulgaris

Thymus Vulgaris extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type 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.

Nigella Sativa

Nigella Sativa extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type 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.

Aloe Vera

Aloe Vera extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type 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.

Formocresol

Formocresol will be used as a dental pulp dressing material after pulpotomy to be compared with other materials.

Group Type ACTIVE_COMPARATOR

Pulpotomy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rana sharaf

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha S Kabil, PHD

Role: STUDY_DIRECTOR

Professor

Basma G Awad, PHD

Role: STUDY_DIRECTOR

Lecturer

Locations

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Faculty of Dentistry, Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Saikiran KV, Kamatham R, Sahiti PS, Nuvvula S. Pulpotomy medicaments in primary teeth: A literature reviewof natural alternatives. SRM J Res Dent Sci 2018; 9:181-5.

Reference Type BACKGROUND

Kumar Praveen NH, Nayak Rashmi, Bhaskar Vipin K, Mopkar Pujan P Pulpotomy Medicaments: Continued Search for New Alternatives- A Review. 2014; OHDM - Vol. 13 - No. 4

Reference Type BACKGROUND

Al-Dlaigan YH. Pulpotomy Medicaments used in Deciduous Dentition: An Update. J Contemp Dent Pract. 2015 Jun 1;16(6):486-503. doi: 10.5005/jp-journals-10024-1711.

Reference Type BACKGROUND

PMID: 26323453 (View on PubMed)

Salman BN, Vahabi S, Rad MM. Use of herbs and medicinal plants in dentistry: a review. Journal Dental School 2017; 35, No. 2: 58-64

Reference Type BACKGROUND

Subramanyam D, Somasundaram S. Clinical and Radiographic Outcome of Herbal Medicine Versus Standard Pulpotomy Medicaments in Primary Molars: A Systematic Review. Journal of Clinical and Diagnostic Research 2017 Oct; 11(10): ZE12-ZE16

Reference Type BACKGROUND

Kumar G, Jalaluddin M, Rout P, Mohanty R, Dileep CL. Emerging trends of herbal care in dentistry. J Clin Diagn Res. 2013 Aug;7(8):1827-9. doi: 10.7860/JCDR/2013/6339.3282. Epub 2013 Aug 1.

Reference Type BACKGROUND

PMID: 24086929 (View on PubMed)

Kuwatada JS, Raja M, Sood P. Turmeric: A Boon to Oral Health. Int J Oral Care Res 2017;5(4):338-341.

Reference Type BACKGROUND

Srivastava R, Jyoti B, Pathak S, Wazir S, Shukla A, Sajid MdZ Aloe Vera: The Herbal Magic Wand. J Clin Den Res Edu 2014; 3 (8).

Reference Type BACKGROUND

Huth KC, Paschos E, Hajek-Al-Khatar N, Hollweck R, Crispin A, Hickel R, Folwaczny M. Effectiveness of 4 pulpotomy techniques--randomized controlled trial. J Dent Res. 2005 Dec;84(12):1144-8. doi: 10.1177/154405910508401210.

Reference Type BACKGROUND

PMID: 16304444 (View on PubMed)

Other Identifiers

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PED19-3D

Identifier Type: -

Identifier Source: org_study_id