Condition category
Oral Health
Date applied
04/11/2019
Date assigned
05/11/2019
Last edited
11/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tooth extraction remains one of the common procedures in developing countries. However, one of a common postoperative complication of extraction is severe pain, so it is important to prescribe some analgesic to relief that pain. The aim of this study is to compare between two commonly prescribed oral analgesics in our country (Saudi Arabia) for reducing pain after tooth extraction with the least side effects (Roxonin , Rabidus).

Who can participate?
Participants over the age of 18, undergoing tooth extraction at the study site

What does the study involve?
Pain assessment was carried out postoperatively by 6 hours and every 12 hours for 3 days using visual analogue scale

What are the possible benefits and risks of participating?
Benefits: reducing post-extraction pain by receiving free analgesics.
Risks: There are no direct risks. If there is an allergy to the treatment the participant will be stopped immediately.

Where is the study run from?
Taibah University College of Dentistry, Saudi Arabia

When is the study starting and how long is it expected to run for?
January 2018 to March 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Majd Almutairi
m.rja_almutairi@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Majd Almutairi

ORCID ID

Contact details

Taibah University College of Dentistry
Prince Naif road
Almadinah
42353
Saudi Arabia
+966 148618332
information@taibahudental.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

TUCDREC/20180102/Alaufi

Study information

Scientific title

Roxonin versus Rabidus in post-dental extraction pain relief and side effects: a randomized, triple-blind, controlled clinical trial

Acronym

Study hypothesis

There will be no difference between Rabidus and Rexonin oral analgesics for controlling post-dental extraction pain and side effects (e.g. vomiting).

Ethics approval

Approved 13/02/2019, Taibah University College of Dentistry Research Ethics Committee (Prince Naif Road, Almadinah, 42353, Saudi Arabia; amramadan@taibahu.edu.sa), ref: TUCDREC/20180102/Alaufi

Study design

Interventional single-centre triple-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Pain after tooth extraction

Intervention

Eligible patients after tooth extraction were randomized to the study interventional groups (Rapidus or Roxonin) by means of drawing lots and intervention and control were coded as A or B. The codes of the drugs were kept by an independent monitor and were unveiled until all data underwent analyses. The researcher, the clinicians, and patients were blinded to the codes of the drugs A and B during the course of the study. When the participant opens the envelope, he/she found the instruction of how to take the medicine as the manufacture instructed.

Medicine was taken for three days and pain assessed by VAS after 6 hours and then every 12 hours for three days.

Intervention type

Drug

Phase

Phase IV

Drug names

Roxonin (Loxoprofen)
Rabidus (Diclofenac Potassium)

Primary outcome measure

Pain after tooth extraction by using VAS (visual analogue scale) , the timepoint was after 6 hours of tooth extraction and every 12 hours for three days.

Secondary outcome measures

Side effects over the trial period (three days)

Overall trial start date

01/01/2018

Overall trial end date

01/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18-70 years old .
2. Literate people (speaking, reading and writing Arabic or English).
3. Healthy or with controlled systemic disease as recommended by the American Society of Anesthesiologists and had no risk from the administration of LA with adrenaline (hyperthyroidism).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Could not give informed consent (e.g. mental disorder)
2. Teeth with reversible pulpitis
3. History of taking anticoagulant, active peptic ulcer and attack of asthma

Recruitment start date

20/01/2018

Recruitment end date

24/03/2018

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Taibah University College of Dentistry
Prince Naif Road
Almadinah
42353
Saudi Arabia

Sponsor information

Organisation

Taibah University College of Dentistry

Sponsor details

Prince Naif road
Almadinah
42353
Saudi Arabia
+966 14-8618888
information@taibahudental.com

Sponsor type

Government

Website

https://www.taibahu.edu.sa

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

20/12/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/11/2019: The Phase was changed from II to IV. 07/11/2019: Internal review. 05/11/2019: Trial’s existence confirmed by Taibah University College of Dentistry Research Ethics Committee