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

Pulpitis - Irreversible Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719247
• Other study ID #: PED19-3D
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Al-Dlaigan YH. Pulpotomy Medicaments used in Deciduous Dentition: An Update. J Contemp Dent Pract. 2015 Jun 1;16(6):486-503. Review. — View 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. — View 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. — View 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

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

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.

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

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).

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 to 6 months
Primary	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	1 to 6 months