Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy (3-mixtatin)
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|ClinicalTrials.gov Identifier: NCT03084601|
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : October 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Necrotic Pulp Postoperative Pain||Drug: Calcium Hydroxide, Iodoform, paste Drug: 3-mixtatin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy: A Randomized Controlled Trial|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||March 1, 2018|
Active Comparator: calcium hydroxide iodoform paste
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 mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin
Other Name: 3mixtatin
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
Other Name: metapex
- pain [ Time Frame: at 3rd months ]measurment of post-operative pain by a questionnaire either present or absent
- swelling [ Time Frame: at 3rd month ]visual inspection either present or absent
- swelling [ Time Frame: at 6th month ]visual inspection either present or absent
- swelling [ Time Frame: at 9th month ]visual inspection either present or absent
- mobility [ Time Frame: at 3rd month ]visual inspection either present or absent
- mobility [ Time Frame: at 6th month ]visual inspection either present or absent
- mobility [ Time Frame: at 9th month ]visual inspection either present or absent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084601
|Pedodontic Department Cairo University|
|Cairo Governorate, Cairo, Egypt, 002|