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

NCT03084601 | Completed Phase 4 DMC

• 1 other identifier: mahmoud 3-mixtatin
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotic Pulp; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• pain

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

  at 3rd months

Secondary Outcomes (6)

• swelling

  at 3rd month

• swelling

  at 6th month

• swelling

  at 9th month

• mobility

  at 3rd month

• mobility

  at 6th month

Study Arms (2)

calcium hydroxide iodoform paste

ACTIVE COMPARATOR

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

EXPERIMENTAL

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

Interventions

Calcium Hydroxide, Iodoform, paste DRUG

mixture of calcium hydroxide and iodoform

Also known as: metapex

3-mixtatin

3-mixtatin DRUG

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

Also known as: 3mixtatin

calcium hydroxide iodoform paste

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahmoud M Saadoon: lead

Study Sites (1)

Pedodontic Department Cairo University

Cairo Governorate, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Interventions

Calcium Hydroxide; iodoform; Ointments; Metapex

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident dr, department of pedodontics, cairo University

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: March 21, 2017
• Study Start: March 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)