Preventive Treatment of Pain After Dental Implant Surgery

• Status: Completed
• Trial end date: 2015-11-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad de Murcia
• Collaborator: Mozo Grau Ticare
• Treatments: Dexketoprofen trometamol; Ketoprofen

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.