Clinical trial NCT03107338: Preventive Treatment of Pain After Dental Implant Surgery
Official title: Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: a Randomized, Double-blind Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Keywords: Pre-emptive analgesia; Dexketoprofen trometamol
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
Collaborators: name: Mozo Grau Ticare
First posted: 2017-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted as a prospective randomized double-blind study with a placebo. The present study considered the checklist items proposed in the CONSORT statement.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Acute pain after implant surgery
timeFrame: 2 years (until complete sample)
Secondary outcomes:
measure: Inflammation
timeFrame: 2 years (until complete sample)
Other outcomes:
Locations:
Study officials:
References: