Preventive Treatment of Pain After Dental Implant Surgery

NCT ID: NCT03107338

Last Updated: 2017-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-11-07

Brief Summary

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.

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.

Conditions

Acute Pain

Keywords

Pre-emptive analgesia; Dexketoprofen trometamol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

DEXKETOPROFEN TROMETAMOL

Patients received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery

Group Type: ACTIVE_COMPARATOR

DEXKETOPROFEN TROMETAMOL

Intervention Type: DRUG

Patients who were administered a single dose of 25 mg of DKT 15 minutes before surgery

Placebo

Patients received a dose of 500 mg Vitamin C in an oral suspension 15 minutes before surgery

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients who were administered a single dose of 500 mg of Vitamin C 15 minutes before surgery

Interventions

DEXKETOPROFEN TROMETAMOL

Patients who were administered a single dose of 25 mg of DKT 15 minutes before surgery

Intervention Type: DRUG

Placebo

Patients who were administered a single dose of 500 mg of Vitamin C 15 minutes before surgery

Intervention Type: OTHER

Other Intervention Names

Enantyum 25

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mozo Grau Ticare

UNKNOWN

Sponsor Role: collaborator

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Arturo Sánchez-Pérez

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

30102009

Identifier Type: -

Identifier Source: org_study_id