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

NCT04719247 | Completed

• 1 other identifier: PED19-3D
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (5)

Turmeric

EXPERIMENTAL

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

Procedure: Pulpotomy

Thymus Vulgaris

EXPERIMENTAL

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

Procedure: Pulpotomy

Nigella Sativa

EXPERIMENTAL

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

Procedure: Pulpotomy

Aloe Vera

EXPERIMENTAL

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

Procedure: Pulpotomy

Formocresol

ACTIVE COMPARATOR

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

Procedure: Pulpotomy

Interventions

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.

Aloe Vera; Formocresol; Nigella Sativa; Thymus Vulgaris; Turmeric

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Location

Related Publications (9)

• 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.

  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

  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.

  PMID: 26323453 BACKGROUND

• 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

  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

  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.

  PMID: 24086929 BACKGROUND

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

  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).

  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.

  PMID: 16304444 BACKGROUND

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Noha S Kabil, PHD

  Professor

  STUDY DIRECTOR

• Basma G Awad, PHD

  Lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: January 22, 2021
• Study Start: November 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)