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

NCT04406883 | Completed Phase 2 DMC

• 1 other identifier: 2093
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain Measurement;Tooth Extraction;Simvastatin.

Outcome Measures

Primary Outcomes (1)

• Pain experienced by patients following the atraumatic tooth extraction, evaluated by using a visual analog pain scale within 24 hours.

  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.

  one day

Study Arms (2)

A (Simavastatin 10 mg with gelatin sponge graft)

ACTIVE COMPARATOR

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

B(Gelatin sponge graft )

ACTIVE COMPARATOR

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

Drug: Extraction + filled with Simvastatin solution impregnated gelatin sponge

Interventions

Extraction + filled with Simvastatin solution impregnated gelatin sponge DRUG

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.

Also known as: Extraction + filled gelatin sponge

A (Simavastatin 10 mg with gelatin sponge graft); B(Gelatin sponge graft )

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

Study Sites (1)

Amirhossein Farahmand

Tehran, 19, Iran

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director,clinical research

Model Details: This study is a Double-blind, Randomized, Parallel-group, split-mouth.

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: May 29, 2020
• Study Start: April 12, 2019
• Primary Completion: December 26, 2019
• Study Completion: February 29, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)