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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
Sponsor:
Information provided by (Responsible Party):
Mahmoud M Saadoon, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Necrotic Pulp Postoperative Pain Drug: Calcium Hydroxide, Iodoform, paste Drug: 3-mixtatin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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 Name: 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 Name: metapex




Primary Outcome Measures :
  1. pain [ Time Frame: at 3rd months ]
    measurment of post-operative pain by a questionnaire either present or absent


Secondary Outcome Measures :
  1. swelling [ Time Frame: at 3rd month ]
    visual inspection either present or absent

  2. swelling [ Time Frame: at 6th month ]
    visual inspection either present or absent

  3. swelling [ Time Frame: at 9th month ]
    visual inspection either present or absent

  4. mobility [ Time Frame: at 3rd month ]
    visual inspection either present or absent

  5. mobility [ Time Frame: at 6th month ]
    visual inspection either present or absent

  6. mobility [ Time Frame: at 9th month ]
    visual inspection either present or absent



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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Egypt
Pedodontic Department Cairo University
Cairo Governorate, Cairo, Egypt, 002
Sponsors and Collaborators
Mahmoud M Saadoon

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Responsible Party: Mahmoud M Saadoon, resident dr, department of pedodontics, cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03084601    
Other Study ID Numbers: mahmoud 3-mixtatin
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Pulp Necrosis
Pain, Postoperative
Necrosis
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents