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

Postoperative Pain Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03084601
Study type	Interventional
Source	Cairo University
Contact
Status	Completed
Phase	Phase 4
Start date	March 1, 2017
Completion date	March 1, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.