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

Study Overview
=================
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.

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

Conditions
-----------------
Pulpitis - Irreversible

Intervention / Treatment
-----------------
* Procedure: Pulpotomy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Turmeric<br>Turmeric extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol | Procedure: Pulpotomy<br>* 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.<br>|
| Experimental: Thymus Vulgaris<br>Thymus Vulgaris extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol | Procedure: Pulpotomy<br>* 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.<br>|
| Experimental: Nigella Sativa<br>Nigella Sativa extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol | Procedure: Pulpotomy<br>* 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.<br>|
| Experimental: Aloe Vera<br>Aloe Vera extract will be used as a dental pulp dressing material after pulpotomy and compared with Formocresol | Procedure: Pulpotomy<br>* 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.<br>|
| Active Comparator: Formocresol<br>Formocresol will be used as a dental pulp dressing material after pulpotomy to be compared with other materials. | Procedure: Pulpotomy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |