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

Sponsor
Islamic Azad University, Tehran (Other)
Overall Status
Completed
CT.gov ID
NCT04406883
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
10.6
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Extraction + filled with Simvastatin solution impregnated gelatin sponge
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a Double-blind, Randomized, Parallel-group, split-mouth.This study is a Double-blind, Randomized, Parallel-group, split-mouth.
Masking:
Single (Participant)
Masking Description:
This event was a double-blind study (neither the patients nor the clinicians were aware of the rinsing solution used). Consequently, all periods of treatment, clinical parameters were recorded by an examiner who was blinded to the kind of medication received by the subjects while another clinician gave treatment.
Primary Purpose:
Treatment
Official Title:
Effects of Simvastatin in the Prevention of Pain Experienced After Tooth Extraction. Double-blind Clinical Trials
Actual Study Start Date :
Apr 12, 2019
Actual Primary Completion Date :
Dec 26, 2019
Actual Study Completion Date :
Feb 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A (Simavastatin 10 mg with gelatin sponge graft)

A group: After atraumatic extraction, filled the tooth socket with Simvastatin10 mg solution impregnated gelatin sponge.

Drug: Extraction + filled with Simvastatin solution impregnated gelatin sponge
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 + 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.
Other Names:
  • Extraction + filled gelatin sponge

    		•
    Active Comparator: B(Gelatin sponge graft )

    B group: Following atraumatic extraction, put in the tooth socket with gelatin sponge.

    Drug: Extraction + filled with Simvastatin solution impregnated gelatin sponge
    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 + 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.
    Other Names:
  • Extraction + filled gelatin sponge

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain experienced by patients following the atraumatic tooth extraction, evaluated by using a visual analog pain scale within 24 hours. [one day]

      The pain level is recorded according to the visual analogue scale (VAS) at the intervals of before treatments, also Postoperative analog pain scores were assessed in 30 minutes to 24 hours later.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Amirhossein Farahmand Tehran Iran, Islamic Republic of 19

    Sponsors and Collaborators

    • Islamic Azad University, Tehran

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amirhossein Farahmand, director,clinical research, Islamic Azad University, Tehran
    ClinicalTrials.gov Identifier:
    NCT04406883
    Other Study ID Numbers:
    • 2093
    First Posted:
    May 29, 2020
    Last Update Posted:
    May 29, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Amirhossein Farahmand, director,clinical research, Islamic Azad University, Tehran
    Pain Measurement;Tooth Extraction;Simvastatin.
    Additional relevant MeSH terms:
    Simvastatin

    Study Results

    No Results Posted as of May 29, 2020