Preventive Treatment of Pain After Dental Implant Surgery

NCT03107338 | Completed Phase 4

• 1 other identifier: 30102009
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Pain

Keywords

Pre-emptive analgesia; Dexketoprofen trometamol

Outcome Measures

Primary Outcomes (1)

• Acute pain after implant surgery

  measured by visual analogue scale (VAS) of 100 mm to measure pain intensity

  2 years (until complete sample)

Secondary Outcomes (1)

• Inflammation

  2 years (until complete sample)

Study Arms (2)

DEXKETOPROFEN TROMETAMOL

ACTIVE COMPARATOR

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

Drug: DEXKETOPROFEN TROMETAMOL

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

DEXKETOPROFEN TROMETAMOL DRUG

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

Also known as: Enantyum 25

DEXKETOPROFEN TROMETAMOL

Placebo OTHER

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Murcia: lead
• Mozo Grau Ticare: collaborator

MeSH Terms

Conditions

Acute Pain

Interventions

dexketoprofen trometamol

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients and the evaluator of the VAS (MMV) were unaware of the results of the randomization and the treatment received.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 11, 2017
• Study Start: September 1, 2013
• Primary Completion: October 30, 2015
• Study Completion: November 7, 2015
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Once the results have been published
• Access Criteria: Any interested researcher