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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)

Primary Purpose

Necrotic Pulp, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Calcium Hydroxide, Iodoform, paste
3-mixtatin
Sponsored by
Mahmoud M Saadoon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Pulp

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pedodontic Department Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

calcium hydroxide iodoform paste

3-mixtatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

pain
measurment of post-operative pain by a questionnaire either present or absent

Secondary Outcome Measures

swelling
visual inspection either present or absent
swelling
visual inspection either present or absent
swelling
visual inspection either present or absent
mobility
visual inspection either present or absent
mobility
visual inspection either present or absent
mobility
visual inspection either present or absent

Full Information

First Posted
February 13, 2017
Last Updated
October 25, 2018
Sponsor
Mahmoud M Saadoon
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1. Study Identification

Unique Protocol Identification Number
NCT03084601
Brief 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
Acronym
3-mixtatin
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahmoud M Saadoon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
calcium hydroxide iodoform paste
Arm Type
Active Comparator
Arm Description
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
Arm Title
3-mixtatin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide, Iodoform, paste
Other Intervention Name(s)
metapex
Intervention Description
mixture of calcium hydroxide and iodoform
Intervention Type
Drug
Intervention Name(s)
3-mixtatin
Other Intervention Name(s)
3mixtatin
Intervention Description
3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin
Primary Outcome Measure Information:
Title
pain
Description
measurment of post-operative pain by a questionnaire either present or absent
Time Frame
at 3rd months
Secondary Outcome Measure Information:
Title
swelling
Description
visual inspection either present or absent
Time Frame
at 3rd month
Title
swelling
Description
visual inspection either present or absent
Time Frame
at 6th month
Title
swelling
Description
visual inspection either present or absent
Time Frame
at 9th month
Title
mobility
Description
visual inspection either present or absent
Time Frame
at 3rd month
Title
mobility
Description
visual inspection either present or absent
Time Frame
at 6th month
Title
mobility
Description
visual inspection either present or absent
Time Frame
at 9th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Pedodontic Department Cairo University
City
Cairo Governorate
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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