Clinical trial NCT04406883: Effects of Simvastatin in the Prevention of Pain Experienced After Tooth Extraction
Official title: Effects of Simvastatin in the Prevention of Pain Experienced After Tooth Extraction. Double-blind Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Pain Measurement;Tooth Extraction;Simvastatin.
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a Double-blind, Randomized, Parallel-group, split-mouth.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain experienced by patients following the atraumatic tooth extraction, evaluated by using a visual analog pain scale within 24 hours.
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Amirhossein Farahmand
Study officials:
References: