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

Primary Purpose

Pulpitis - Irreversible

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Pulpotomy

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Turmeric

Thymus Vulgaris

Nigella Sativa

Aloe Vera

Formocresol

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Clinical signs and symptoms of pulp reaction

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

Radiographic signs of pulp reaction

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04719247

First Posted

October 9, 2020

Last Updated

December 7, 2021

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04719247

Brief Title

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

Acronym

RCT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

May 1, 2021 (Actual)

Study Completion Date

November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulpitis - Irreversible

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Turmeric

Arm Type

Experimental

Arm Description

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

Arm Title

Thymus Vulgaris

Arm Type

Experimental

Arm Description

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

Arm Title

Nigella Sativa

Arm Type

Experimental

Arm Description

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

Arm Title

Aloe Vera

Arm Type

Experimental

Arm Description

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

Arm Title

Formocresol

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Pulpotomy

Intervention Description

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 Outcome Measure Information:

Title

Clinical signs and symptoms of pulp reaction

Description

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

Time Frame

1 to 6 months

Title

Radiographic signs of pulp reaction

Description

Time Frame

1 to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noha S Kabil, PHD

Organizational Affiliation

Professor

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Basma G Awad, PHD

Organizational Affiliation

Lecturer

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry, Ain Shams University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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.

Results Reference

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Citation

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

Results Reference

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PubMed Identifier

26323453

Citation

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.

Results Reference

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Citation

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

Results Reference

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Citation

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

Results Reference

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PubMed Identifier

24086929

Citation

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.

Results Reference

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Citation

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

Results Reference

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Citation

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).

Results Reference

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PubMed Identifier

16304444

Citation

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.

Results Reference

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

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