Impacted Third Molar ToothNCT04874675
An Randomized Control Trial Comparing Two Drug Combinations for Pain Management After Third Molars Surgery
A study testing diclofenac / acetaminophen /codeine and ibuprofen/acetaminophen/codeine in people with Impacted Third Molar Tooth and PAIN, run by University of Zimbabwe at 1 site in Zimbabwe.
Trial summary
Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth, PAIN
- What is being tested?
- diclofenac / acetaminophen /codeine and ibuprofen/acetaminophen/codeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteZimbabwe
- Study dates
- Mar 2023to Apr 2024
- Phase
- Interventional
- 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
- patients older than 18 years of age
- patients undergoing third molar extractions
- patients with or willing to get orthopantomogram for assessment of impacted third molars
Who cannot join
- patients younger than 18 years
- patients not willing to consent to the study
- patients with associated co-morbidities
- patients not willing to undergo radiological evaluation
- patients allergic to medications used in the study
- pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery
Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of Diclofenac/ acetaminophen/codeine and ibuprofen/acetaminophen/codeine .
Read the detailed description
Double blind randomized control clinical trial to compare the level of pain relief that occurs after third molar extraction done under local anaesthesia at the maxillofacial center, Harare, Zimbabwe. The participants will be randomized into two arms upon fitting the inclusion criteria.The pharmacist will be in charge of randomization and will randomise the participants upon giving them the medications. One group will receive combination of diclofenac/acetaminophen/codeine and the other group will receive ibuprofen/acetaminophen/codeine as post extraction analgesia.The dosages of the medications will be Diclofenac 50mg, ibuprofen 400mg, acetaminophen 500mg and codeine 15mg respectively. Questionnaires will be given to the patient to complete after discharge from the surgery and other parts of the questionnaire will be completed on review after 7 days. A record will be done of the postoperative pain experience (using visual analogue scale), use of rescue medication and details pertaining to impacted tooth.
- Conditions
- Impacted Third Molar Tooth, PAIN
- Being tested
- diclofenac / acetaminophen /codeine, ibuprofen/acetaminophen/codeine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac / acetaminophen /codeineDrug
Also called diclofenac/paracetamol/codeine phosphate
routine pain medication used post extraction of third molars
ibuprofen/acetaminophen/codeineDrug
Also called ibuprofen/paracetamol/codeine phosphate
routine pain medication used post extraction of third molars
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac /Acetaminophen/Codeine | Active comparator | routine pain medication used in post extraction pain management Receives: Drug: diclofenac / acetaminophen /codeine |
| Ibuprofen/Acetaminophen/codeine | Active comparator | routine pain medication used in post extraction pain management Receives: Drug: ibuprofen/acetaminophen/codeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
record of pain felt by patients on Visual analogue scale using a smiling face to show no pain and worst pain ever with a sad face measured line at 100mm . a score of 100mm indication worst pain and score of 0mm indicating no pain.
Measured: within 7 days post extraction
Secondary outcomes (2)
Time rescue medication is used
rescue medication
Measured: within 7 days post extraction
cheek swelling
amount of cheek swelling post extraction
Measured: with in 7 days post extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study startMar 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: Covid 19 lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zimbabwe
- Sponsor type
- University, hospital or other
- Collaborators
- UZ-CHS-PERFECT
- Responsible party
- Principal investigator, Silas Bere, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874675
- Sponsor's protocol ID
- UZCHS PERFECT THIRD MOLAR
- Status last verified
- Jan 2023
- First submitted
- 28 Apr 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery
- ClinicalTrials.gov ID
- NCT04874675
- Acronym / sponsor ID
- UZCHS PERFECT THIRD MOLAR
- Conditions
- Impacted Third Molar Tooth, PAIN
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Covid 19 lockdown
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of ZimbabweUniversity, hospital or other
- Collaborators
- UZ-CHS-PERFECT
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 6 May 2021 (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.
Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of Diclofenac/ acetaminophen/codeine and ibuprofen/acetaminophen/codeine .
Detailed description
Double blind randomized control clinical trial to compare the level of pain relief that occurs after third molar extraction done under local anaesthesia at the maxillofacial center, Harare, Zimbabwe. The participants will be randomized into two arms upon fitting the inclusion criteria.The pharmacist will be in charge of randomization and will randomise the participants upon giving them the medications. One group will receive combination of diclofenac/acetaminophen/codeine and the other group will receive ibuprofen/acetaminophen/codeine as post extraction analgesia.The dosages of the medications will be Diclofenac 50mg, ibuprofen 400mg, acetaminophen 500mg and codeine 15mg respectively. Questionnaires will be given to the patient to complete after discharge from the surgery and other parts of the questionnaire will be completed on review after 7 days. A record will be done of the postoperative pain experience (using visual analogue scale), use of rescue medication and details pertaining to impacted tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac /Acetaminophen/Codeine | Active comparator | Drug: diclofenac / acetaminophen /codeineroutine pain medication used in post extraction pain management |
| Ibuprofen/Acetaminophen/codeine | Active comparator | Drug: ibuprofen/acetaminophen/codeineroutine pain medication used in post extraction pain management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients older than 18 years of age
- patients undergoing third molar extractions
- patients with or willing to get orthopantomogram for assessment of impacted third molars
Key exclusion criteria (6 listed)
- patients younger than 18 years
- patients not willing to consent to the study
- patients with associated co-morbidities
- patients not willing to undergo radiological evaluation
- patients allergic to medications used in the study
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 |
|---|---|---|
| diclofenac / acetaminophen /codeineAlso: diclofenac/paracetamol/codeine phosphateroutine pain medication used post extraction of third molars | Drug | Diclofenac /Acetaminophen/Codeine |
| ibuprofen/acetaminophen/codeineAlso: ibuprofen/paracetamol/codeine phosphateroutine pain medication used post extraction of third molars | Drug | Ibuprofen/Acetaminophen/codeine |
Primary outcome
post operative pain
Time frame: within 7 days post extraction
record of pain felt by patients on Visual analogue scale using a smiling face to show no pain and worst pain ever with a sad face measured line at 100mm . a score of 100mm indication worst pain and score of 0mm indicating no pain.
2 secondary outcomes
Time rescue medication is used
Time frame: within 7 days post extraction
cheek swelling
Time frame: with in 7 days post extraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diclofenac / acetaminophen /codeine and ibuprofen/acetaminophen/codeine in people with Impacted Third Molar Tooth and PAIN, run by University of Zimbabwe at 1 site in Zimbabwe.
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 3 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: paused, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
post operative pain (time frame: within 7 days post extraction). 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 5 Jan 2023.