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The aim of the current study is to compare a newly introduced material which is a combination of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is named 3MIX-TATIN & will be compared to triple antibiotic paste for management of necrotic primary molars by using lesion sterilization and tissue repair LSTR technique.
3Mix-tatin will prepared by mixing three commercially available antibiotics with simvastatin. After removing the coating materials, 3 types of antibiotics are pulverized by porcelain mortars and pestles to achieve fine powders. A total of 100 mg ciprofloxacin, 100 mg metronidazole, and 100 mg cefixime will be mixed in a ratio of 1: 1: 1. Two milligrams of simvastatin will be added to the drugs blend to form 3-Mix-tatin. Preparation of 3Mixtatin will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly capped porcelain container, adding a small amount of silica gel in a bag inside the container to maintain low humidity. This powder will be mixed with normal saline to form a creamy paste of 3Mixtatin at the time of application.
Local anesthesia using mepivicaine hydrochloride 3% (septodont, saint-maurdesFosses, France) will be administered.
Rubber dam isolation.
Access cavity will be prepared with a fissure bur in a high-speed handpiece, necrotic pulp tissue will be removed using a sterile sharp spoon excavator.
The canal orifices will be enlarged with a round bur (one mm diameter and two mm depth) to create medication receptacles.
Cotton pellet moistened with 2.5% sodium hypochlorite (NaOCl) will be placed in the pulp chamber for 1 minute.
Bleeding, if present, will be controlled by applying sterile cotton pellet moistened with 10% sodium hypochlorite against the pulp stumps and will be maintained for 1 min.
The 3-Mix-Tatin will be mixed with saline to obtain a creamy mix and placed over the canal orifices and the pulpal floor.
The access opening will be sealed with a glass ionomer cement , and the tooth will be restored with a stainless steel crown.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| calcium hydroxide iodoform paste | Active Comparator | intervention administered to control group is a combination of drugs as follow: ciprofloxacin 500mg, cefixime 500 mg, metronidazole 500 mg, simvastain 40mg. all are mixed, placed in pulp chamber only one time and tooth is restored |
|
| 3-mixtatin | Experimental | intervention administered to experimental group is a ready made mixture of calcium hydroxide and iodoform, placed in pulp chamber only one time and tooth is restored |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Hydroxide, Iodoform, paste | Drug | mixture of calcium hydroxide and iodoform |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain | measurment of post-operative pain by a questionnaire either present or absent | at 3rd months |
| Measure | Description | Time Frame |
|---|---|---|
| swelling | visual inspection either present or absent | at 3rd month |
| swelling | visual inspection either present or absent | at 6th month |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pedodontic Department Cairo University | Cairo Governorate | Cairo Governorate | 002 | Egypt |
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| 3-mixtatin | Drug | 3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin |
|
|
| swelling | visual inspection either present or absent | at 9th month |
| mobility | visual inspection either present or absent | at 3rd month |
| mobility | visual inspection either present or absent | at 6th month |
| mobility | visual inspection either present or absent | at 9th month |
| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002126 | Calcium Hydroxide |
| C010473 | iodoform |
| D009824 | Ointments |
| C498115 | Metapex |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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