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Completed

NCT Number: 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

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.

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pedodontic Department Cairo University

Cairo Governorate, 002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium Hydroxide, Iodoform, paste

Drug

mixture of calcium hydroxide and iodoform

Other names: metapex

3-mixtatin

Drug

3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin

Other names: 3mixtatin

Primary outcomes

  1. pain

    Time frame: at 3rd months

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahmoud M Saadoon

Other

Registry information

Official study 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

Acronym: 3-mixtatin

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2017
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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