A Phase 4 interventional study of Calcium Hydroxide, Iodoform, paste and 3-mixtatin in Necrotic Pulp and Postoperative Pain, sponsored by Mahmoud M Saadoon. Completed at 1 site in Egypt. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by Mahmoud M Saadoon · Phase 4, Interventional, and Treatment
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.
149 studies on the registry are indexed under Dental Pulp Necrosis; 39 are open to participants now.
This study's enrollment of 100 is above the median of 44 across 139 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →This is the only study on the registry with Mahmoud M Saadoon as lead sponsor.
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Exclusion criteria:
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
Drug: 3-mixtatin
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
Drug: Calcium Hydroxide, Iodoform, paste
mixture of calcium hydroxide and iodoform
Also known as: metapex
3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin
Also known as: 3mixtatin
pain
measurment of post-operative pain by a questionnaire either present or absent
Time frame: at 3rd months
swelling
visual inspection either present or absent
Time frame: at 3rd month
swelling
visual inspection either present or absent
Time frame: at 6th month
swelling
visual inspection either present or absent
Time frame: at 9th month
mobility
visual inspection either present or absent
Time frame: at 3rd month
mobility
visual inspection either present or absent
Time frame: at 6th month
mobility
visual inspection either present or absent
Time frame: at 9th month
Plan to share: No
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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