Pedodontic Department Cairo University
Cairo Governorate, 002, Egypt
NCT Number: NCT03084601
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.
Looking for future studies?
Notify Me5 year–8 year
All sexes
Interventional
Phase 4
Cairo Governorate, 002, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
mixture of calcium hydroxide and iodoform
Other names: metapex
3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin
Other names: 3mixtatin
Time frame: at 3rd months
measurment of post-operative pain by a questionnaire either present or absent
Time frame: at 3rd month
visual inspection either present or absent
Time frame: at 6th month
visual inspection either present or absent
Time frame: at 9th month
visual inspection either present or absent
Time frame: at 3rd month
visual inspection either present or absent
Time frame: at 6th month
visual inspection either present or absent
Time frame: at 9th month
visual inspection either present or absent
Mahmoud M Saadoon
Other
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
Acronym: 3-mixtatin
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04983524
Dental Pulp Diseases, Dental Pulp Necrosis
View Trial DetailsNCT07327996
Dental Pulp Diseases, Dental Pulp Necrosis
Cairo, New Cairo, Egypt
View Trial DetailsNCT06926322
Dental Pulp Diseases, Dental Pulp Necrosis
Cairo, Egypt
View Trial DetailsNCT06931678
Apical Periodontitis, Dental Pulp Diseases
Ankara, Etlik, Turkey (Türkiye)
View Trial Details