NCT03084601

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mahmoud M Saadoon · Academic / Other
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Necrotic Pulp
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Calcium Hydroxide, Iodoform, paste	mixture of calcium hydroxide and iodoform
DRUG	3-mixtatin	3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-01-01
• Completion: 2018-03-01
• First posted: 2017-03-21
• Last updated: 2018-10-26

Locations

1 site across 1 country: Egypt