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Effects of Simvastatin in the Prevention of Pain Experienced After Tooth Extraction

I

Islamic Azad University, Tehran

Status and phase

Completed
Phase 2

Conditions

Pain

Treatments

Drug: Extraction + filled with Simvastatin solution impregnated gelatin sponge

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Atraumatic extraction of maxillary premolar teeth (on the Right, left side) was done; Subsequently, the patients were randomly divided into two equal groups: A group (Extraction + filled with a Simvastatin solution impregnated gelatin sponge) and B group (Extraction + without Simvastatin solution impregnated gelatin sponge), were placed in one of the sockets; the pain level is recorded according to the VAS scores at the intervals of before treatments, also Postoperative analog pain scores were assessed in 30 minutes, 6 hours, 12 hours and 24 hours.

Full description

The method of procedure was performed by the same surgeon under local anesthesia (Lidocaine 2% with epinephrine 1:100,000, made by Darou Pakhsh Pharmaceutical Co; Tehran-Iran) to avoid bias. All two first premolars were extracted carefully, have used periotome as a means of atraumatic extraction that facilitated the removal of teeth with minimum damage to the surrounding alveolar bone, teeth to be extracted should have minimum periapical changes radiographically; with decreasing soft tissue reflection; the socket was tan gently irrigated with normal saline and hemostasis was achieved. It must be noted that A group (Extraction + Simvastatin filled with Simvastatin (Poursina Pharmaceutical Co. Tehran-Iran) solution impregnated gelatin sponge (Maquira Industry Dental Products S.A. Brazil) and B group (Extraction + without Simvastatin solution impregnated gelatin sponge), was placed in one of the sockets.

Enrollment

40 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy patients Age group 18-35 years Sulcular probing not more than 3 mm and no redness The determination for extraction of teeth (two maxillary first premolars)for orthodontic treatment A tooth requiring an atraumatic extraction technique.

Exclusion criteria

Systemic diseases Smoking habits; pregnancy or breastfeeding Periodontitis; Teeth having radiographically obvious large periapical Lesion(abscess/granuloma/cyst) T the history of Chemotherapy Radiation therapy Periodontal and the use of any medicine (antibiotics; steroids; non-steroidal anti-inflammatory drugs Allergy to Simvastatin.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

A (Simavastatin 10 mg with gelatin sponge graft)
Active Comparator group
Description:
A group: After atraumatic extraction, filled the tooth socket with Simvastatin10 mg solution impregnated gelatin sponge.
Treatment:
Drug: Extraction + filled with Simvastatin solution impregnated gelatin sponge
B(Gelatin sponge graft )
Active Comparator group
Description:
B group: Following atraumatic extraction, put in the tooth socket with gelatin sponge.
Treatment:
Drug: Extraction + filled with Simvastatin solution impregnated gelatin sponge

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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