Necrotic Pulp, Postoperative Pain
Conditions
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.
Interventions
mixture of calcium hydroxide and iodoform
DRUG3-mixtatin
3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin
Sponsors
Mahmoud M Saadoon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain | at 3rd months | measurment of post-operative pain by a questionnaire either present or absent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| swelling | at 3rd month | visual inspection either present or absent |
| mobility | at 3rd month | visual inspection either present or absent |
Countries
Egypt
Outcome results
None listed