Clinical trial NCT04719247: Clinical and Radiographic Evaluation of Turmeric, Thymus Vulgaris, Nigella Sativa and Aloe Vera as Pulpotomy Medicaments in Primary Teeth
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
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis - Irreversible
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical signs and symptoms of pulp reaction
timeFrame: 1 to 6 months
measure: Radiographic signs of pulp reaction
timeFrame: 1 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
affiliation: Professor
name: Noha S Kabil, PHD
role: STUDY_DIRECTOR
affiliation: Lecturer
name: Basma G Awad, PHD
role: STUDY_DIRECTOR
References:
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