Preventive Treatment of Pain After Dental Implant Surgery

Phase 4

Completed

• Conditions: Acute Pain
• Interventions: Drug: DEXKETOPROFEN TROMETAMOL; Other: Placebo

• Registration Number: NCT03107338
• Lead Sponsor: Universidad de Murcia

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.

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-10-30
• Study Completion: 2015-11-07
• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-11
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXKETOPROFEN TROMETAMOL	DEXKETOPROFEN TROMETAMOL	Patients received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery
Placebo	Placebo	Patients received a dose of 500 mg Vitamin C in an oral suspension 15 minutes before surgery

Primary Outcome Measures

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

Secondary Outcome Measures

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