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

Not Applicable

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Procedure: Pulpotomy

• Registration Number: NCT04719247
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2021-01-17
• Study First Posted: 2021-01-22
• Primary Completion: 2021-05-01
• Study Completion: 2021-11-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formocresol	Pulpotomy	Formocresol will be used as a dental pulp dressing material after pulpotomy to be compared with other materials.
Aloe Vera	Pulpotomy	Aloe Vera extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol
Nigella Sativa	Pulpotomy	Nigella Sativa extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol
Thymus Vulgaris	Pulpotomy	Thymus Vulgaris extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol
Turmeric	Pulpotomy	Turmeric extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol

Primary Outcome Measures

Name	Time	Method
Clinical signs and symptoms of pulp reaction	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
Radiographic signs of pulp reaction	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

Trial Locations

Locations (1)

Faculty of Dentistry, Ain Shams University; 🇪🇬 Cairo, Egypt