Preventive Treatment of Pain After Dental Implant Surgery (UMU)

Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: a Randomized, Double-blind Controlled Trial.

The objective of this prospective randomized double-blind study was to evaluate the effects of the preoperative administration of dexketoprofen trometamol (DKT) on the pain perceived by patients after oral surgery for implant placement.

Materials and Method: Single oral doses of 25 mg DKT or PLACEBO were administered 15 minutes before the performance of conventional implant surgery to assess the influence of the DKT on pain as reported by the patients. One hundred patients who required single-implant treatments were randomly distributed into one of the two blinded groups following a preliminary examination. Fifteen minutes before surgery, the patients in the test group were given 25 mg DKT (DKT group), and those in the control group were given 500 mg vitamin C as a placebo (PLACEBO group). The patients' pain intensities were measured using a subjective visual analogue scale of 100 mm in length, and pain was measured over a period of 7 days. Inflammation was assessed using a 5-point Likert scale on days 2 and 7.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: DEXKETOPROFEN TROMETAMOL; Other: Placebo

Detailed Description

A total of 100 consecutive patients (November 2013 to October 2015) scheduled for implant surgery in the University Dental Clinic (Murcia, Spain) were included in this study. All patients were older than 18 and were free of medical and surgical contraindications and systemic disease that would conflict with treatment (American Society of Anesthesiologists (ASA) risk I or II). All participants in the study were able to read, understand and respond to the health questionnaire and were able to sign an informed consent document. This study was performed in accordance with the 2014 revision of the Declaration of Helsinki (General Assembly of the World Medical Association, 2014).

Clinical materials The study protocol was approved by the Ethics Committee of the University of Murcia.

The study was conducted with a double blind randomized design using a visual analogue scale (VAS) of 100 mm to measure pain intensity. The degree of inflammation was measured using a 5-point Likert scale (extremely inflamed, very inflamed, inflamed, somewhat inflamed, and not inflamed).

Patients signed two informed consent forms, one for the implant surgery, and the other for participation in the study; the latter explicitly mentioned the patients' ability to leave the study at any time.

A local anaesthetic composed of lidocaine hydrochloride and epinephrine (20 mg/ml + 0.0125 mg/ml, respectively) was applied (never alveolar nerve block).

All implants had sandblasted and acid-etched surfaces (TiCare Inhex®, Mozo Grau / Ticare, Valladolid, Spain). All implants were placed by the same surgeon (ASP) following the recommendations of the manufacturer (total = 100 implants).

The test group received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery, and the control group received 500 mg vitamin C 15 minutes before surgery. Both solutions were administered in an orange disposable cup to mask the small difference in colour.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good systemic health status (ASA I or II).
• No current pain.
• No use of painkillers in the prior weeks.
• Older than 18 years.
• Oral hygiene index of < 2 (Löe and Silness).
• A minimum of 2 mm of adhered gum.
• A minimum of 8 mm of vertical bone.
• A minimum of 7 mm of vestibule-lingual bone.
• Scheduled to receive a unitary implant.
• Willing to participate in this controlled study.

Exclusion Criteria:

• Pregnant or nursing women.
• The use of any type of medication that might affect the perception of pain.
• Level of pain greater than 40 mm on the VAS before surgery.
• An history of alcohol or drug abuse.
• Requirement for guided regeneration or maxillary sinus lifting procedures.
• Failure to comply with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: DEXKETOPROFEN TROMETAMOL; Patients received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery	Drug: DEXKETOPROFEN TROMETAMOL; Patients who were administered a single dose of 25 mg of DKT 15 minutes before surgery; Other Names: Enantyum 25
PLACEBO_COMPARATOR: Placebo; Patients received a dose of 500 mg Vitamin C in an oral suspension 15 minutes before surgery	Other: Placebo; Patients who were administered a single dose of 500 mg of Vitamin C 15 minutes before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute pain after implant surgery	measured by visual analogue scale (VAS) of 100 mm to measure pain intensity	2 years (until complete sample)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	Degree of inflammation was measured using a 5-point Likert scale (extremely inflamed, very inflamed, inflamed, somewhat inflamed, and not inflamed).	2 years (until complete sample)

Collaborators and Investigators

• Sponsor: Universidad de Murcia
• Collaborators: Mozo Grau Ticare

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2013
• Primary Completion (ACTUAL): October 30, 2015
• Study Completion (ACTUAL): November 7, 2015

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (ACTUAL): April 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 26, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Pre-emptive analgesia; Dexketoprofen trometamol
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dexketoprofen trometamol
• Other Study ID Numbers: 30102009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data there will be share by personal e-mail
• IPD Sharing Time Frame: Once the results have been published
• IPD Sharing Access Criteria: Any interested researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• 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.: No