Acute PainPhase 4UMUNCT03107338
Preventive Treatment of Pain After Dental Implant Surgery
A Phase 4 study testing DEXKETOPROFEN TROMETAMOL in people with Acute Pain, run by Universidad de Murcia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- DEXKETOPROFEN TROMETAMOL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to 7 Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
About this study
Official title: Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: a Randomized, Double-blind Controlled Trial.
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.
Read the 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
- Being tested
- DEXKETOPROFEN TROMETAMOL, Placebo
- Keywords
- Pre-emptive analgesia; Dexketoprofen trometamol
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXKETOPROFEN TROMETAMOLDrug
Also called Enantyum 25
Patients who were administered a single dose of 25 mg of DKT 15 minutes before surgery
PlaceboOther
Patients who were administered a single dose of 500 mg of Vitamin C 15 minutes before surgery
| Study group | Role | What they receive |
|---|---|---|
| DEXKETOPROFEN TROMETAMOL | Active comparator | Patients received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery Receives: Drug: DEXKETOPROFEN TROMETAMOL |
| Placebo | Placebo comparator | Patients received a dose of 500 mg Vitamin C in an oral suspension 15 minutes before surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute pain after implant surgery
measured by visual analogue scale (VAS) of 100 mm to measure pain intensity
Measured: 2 years (until complete sample)
Secondary outcomes (1)
Inflammation
Degree of inflammation was measured using a 5-point Likert scale (extremely inflamed, very inflamed, inflamed, somewhat inflamed, and not inflamed).
Measured: 2 years (until complete sample)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startSep 2013
- Primary completion30 Oct 2015
- Study completion7 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Mozo Grau Ticare
- Responsible party
- Principal investigator, Arturo Sánchez-Pérez, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107338
- Sponsor's protocol ID
- 30102009
- Acronym
- UMU
- Status last verified
- Nov 2017
- First submitted
- 16 Mar 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data there will be share by personal e-mail
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Preoperative Administration of Dexketoprofen Trometamol on Pain and Swelling After Implant Surgery: a Randomized, Double-blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT03107338
- Acronym / sponsor ID
- UMU / 30102009
- Conditions
- Acute Pain
- Keywords
- Pre-emptive analgesia; Dexketoprofen trometamol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Collaborators
- Mozo Grau Ticare
- Study start
- Sep 2013 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 7 Nov 2015 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DEXKETOPROFEN TROMETAMOL | Active comparator | Drug: DEXKETOPROFEN TROMETAMOLPatients received a dose of 25 mg DKT in an oral suspension 15 minutes before surgery |
| Placebo | Placebo comparator | Other: PlaceboPatients received a dose of 500 mg Vitamin C in an oral suspension 15 minutes before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXKETOPROFEN TROMETAMOLAlso: Enantyum 25Patients who were administered a single dose of 25 mg of DKT 15 minutes before surgery | Drug | DEXKETOPROFEN TROMETAMOL |
| PlaceboPatients who were administered a single dose of 500 mg of Vitamin C 15 minutes before surgery | Other | Placebo |
Primary outcome
Acute pain after implant surgery
Time frame: 2 years (until complete sample)
measured by visual analogue scale (VAS) of 100 mm to measure pain intensity
1 secondary outcome
Inflammation
Time frame: 2 years (until complete sample)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Individual participant dataSharing planned: Yes. All data there will be share by personal e-mail
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEXKETOPROFEN TROMETAMOL in people with Acute Pain, run by Universidad de Murcia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute pain after implant surgery (time frame: 2 years (until complete sample)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.