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)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Necrotic Pulp
• Intervention / Treatment: Drug: 3-mixtatin; Drug: Calcium Hydroxide, Iodoform, paste

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Cairo Governorate, Cairo, Egypt, 002
      • Pedodontic Department Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children age range from 5-8 years.
• Children free from any systemic diseases or medical problems.
• Primary molar with necrotic pulp, with pain, gingival abscess, fistula openings, or clinical mobility not exceeding grade two.
• Radiographic evidence of non-perforating internal resorption, external resorption not exceeding 1\3 of the root, furcation or periapical radiolucency.

Exclusion criteria:

• Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean (Balaji, 2007).
• Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs.
• Patient with facial cellulitis or lymphadenopathy
• Lack of patient/parent compliance and cooperation.
• Refusal of participation or failure to obtain an informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: 3-mixtatin; 3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin; Other Names: 3mixtatin
Experimental: 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; Other Names: metapex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	measurment of post-operative pain by a questionnaire either present or absent	at 3rd months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
swelling	visual inspection either present or absent	at 3rd month
swelling	visual inspection either present or absent	at 6th month
swelling	visual inspection either present or absent	at 9th month
mobility	visual inspection either present or absent	at 3rd month
mobility	visual inspection either present or absent	at 6th month
mobility	visual inspection either present or absent	at 9th month

Collaborators and Investigators

• Sponsor: Mahmoud M Saadoon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Necrosis; Dental Pulp Necrosis; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: mahmoud 3-mixtatin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No