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The aim of this study is to evaluate and compare the clinical effectiveness of zinc oxide-propolis mixture with triple antibiotic paste in LSTR as root canal filling material in necrotic primary molars.
The promising results of propolis as a natural antibiotic in previous in- vivo studies made it interesting to combine propolis to the golden standard zinc oxide eugenol as an intracanal medication in pulp affected primary molars and use this mix as a natural substitute to the modified triple antibiotic paste (m-TAP) and therefore overcoming the antibiotic bacterial resistance, allergy and developmental anomalies that might arise in permanent successor teeth from m-TAP usage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc-oxide Propolis (Zno-P) | Experimental | Propolis liquid (Brazilian Green Bee Propolis Liquid Extract, Uniflora®) and Zinc oxide powder will be mixed and added after minimal instrumentation until size 20 to remove all the accessible necrotic pulp and placed on the pulpal floor and intracanal. |
|
| Modified triple antibiotic paste | Active Comparator | Metronidazole tablets 500 mg (Flagyl®, Sanofi, Egypt), ciprofloxacin tablets 500 mg (Ciprofloxacin tablets USP 39®, European pharmaceuticals, Egypt,), and clindamycin capsules 300 mg(Dalacin C™ Pfizer, Egypt) will be mixed and added after minimal instrumentation until size 20 to remove all the accessible necrotic pulp and placed on the pulpal floor and intracanal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc oxide propolis | Combination Product | Propolis liquid (Brazilian Green Bee Propolis Liquid Extract, Uniflora®) and Zinc oxide powder will be mixed on a glass slab with the help of a stainless -steel spatula. • The mixing ratio of zinc oxide powder and Propolis liquid is 2:1 until a paste like consistency is reached. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Binary outcome measured with direct questioning to the patient | 1 year |
| Tenderness to percussion | (binary outcome measured by percussion test using back of the dental mirror | 1 year |
| Swelling / sinus tract | binary outcome measured with visual examination of the patient examination of the patient | 1 year |
| Mobility | (measured by mobility test) and according to Miller's Grades; reduction in grade of mobility from preoperative baseline was treated as success | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic success | The amount of furcation / periapical radiolucency in comparison to preoperative remained static or decreased | 6 months |
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Inclusion Criteria:
Children:
Teeth:
Clinical criteria:
Radiographic criteria:
Exclusion Criteria:
Children:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Kh Adam, Master | Contact | 01221709929 | sara.khaled@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sherine Badr, Professor | Cairo University | Study Director |
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Data may be provided upon request
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007239 | Infections |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Double
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| Modified triple antibiotic paste | Combination Product | Chemotherapeutic agents used are metronidazole tablets 500 mg (Flagyl®, Sanofi, Egypt), ciprofloxacin tablets 500 mg (Ciprofloxacin tablets USP 39®, European pharmaceuticals, Egypt,), and clindamycin capsules 300 mg(Dalacin C™ Pfizer, Egypt).
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |