Impacted Third Molar ToothEarly Phase 1NCT04848259
Effect of Honey and Dexamethason on Extraction Healing
A Early Phase 1 study testing Normal saline, Dexamethasone and Honey in people with Impacted Third Molar Tooth, run by Al-Azhar University at 1 site in Saudi Arabia.
Trial summary
Natural honey and dexamethason will be given before impaction removal then postoperative complications will be evaluated Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Normal saline, Dexamethasone and Honey
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Jan 2021to 27 Jun 2021
- Phase
- Early Phase 1
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- impacted 3rd molar
- healthy patient No smoking
Who cannot join
- history of smoking Medical disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Therapeutic Approach for Controlling Complications Associated With Impacted Mandibular Third Molar Removal
Natural honey and dexamethason will be given before impaction removal then postoperative complications will be evaluated
Read the detailed description
Patient with impacted lower third molar will be selected to this study agording to agent applied preoperative. Group 1 will receive topical honey and Group 2 will receive IV dexamethason. After surgical removal of impacted tooth under local anesthesia postoperative pain mouth opening, and swelling will be evaluated
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Normal saline, Dexamethasone, Honey, Dexamethasone and honey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Saline will be applied after surgery
DexamethasoneDrug
Dexamethason will be given IV before surgery
HoneyDrug
Honey will be applied locally after surgery
Dexamethasone and honeyDrug
Dexamethason will be given IV before surgery and then Honey will be applied locally after surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No drug given before surgery Receives: Drug: Normal saline |
| Dexamethason | Active comparator | Dexamethason will be given IV before surgery Receives: Drug: Dexamethasone |
| Natural honey | Active comparator | Honey will be placed locally after impaction removal Receives: Drug: Honey |
| Dexamethason and natural honey | Active comparator | Dexamethason will be given IV before surgery and Honey will be placed locally after impaction removal Receives: Drug: Dexamethasone and honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interincisal distance
Distance between upper and lower teeth will be measured in mm by ruler
Measured: Preoperative
Interincisal distance
Distance between upper and lower teeth will be measured in mm by ruler
Measured: I day postoperative
Interincisal distance
Distance between upper and lower teeth will be measured in mm by ruler
Measured: 3rd day postoperative
Interincisal distance
Distance between upper and lower teeth will be measured in mm by ruler
Measured: 7th day postoperative
Edema
Measured from angle of mandible to angle of mouth
Measured: Preoperative
Edema
Measured from angle of mandible to angle of mouth
Measured: 1day postoperative
Edema
Measured from angle of mandible to angle of mouth in mm by ruler
Measured: 2nd day postoperative
Edema
Measured from angle of mandible to angle hof mouth in mm by ruler
Measured: 3rd day postoperative
Edema
Measured from angle of mandible to angle of mouth in mm by ruler
Measured: 7th day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start5 Jan 2021
- Primary completion20 Jun 2021
- Study completion27 Jun 2021
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.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Altaweel, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848259
- Sponsor's protocol ID
- Impaction
- Status last verified
- Jul 2021
- First submitted
- 14 Apr 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Therapeutic Approach for Controlling Complications Associated With Impacted Mandibular Third Molar Removal
- ClinicalTrials.gov ID
- NCT04848259
- Acronym / sponsor ID
- Impaction
- Conditions
- Impacted Third Molar Tooth
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 27 Jun 2021 (actual)
- First posted
- 19 Apr 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.
Natural honey and dexamethason will be given before impaction removal then postoperative complications will be evaluated
Detailed description
Patient with impacted lower third molar will be selected to this study agording to agent applied preoperative. Group 1 will receive topical honey and Group 2 will receive IV dexamethason. After surgical removal of impacted tooth under local anesthesia postoperative pain mouth opening, and swelling will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Normal salineNo drug given before surgery |
| Dexamethason | Active comparator | Drug: DexamethasoneDexamethason will be given IV before surgery |
| Natural honey | Active comparator | Drug: HoneyHoney will be placed locally after impaction removal |
| Dexamethason and natural honey | Active comparator | Drug: Dexamethasone and honeyDexamethason will be given IV before surgery and Honey will be placed locally after impaction removal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- impacted 3rd molar
- healthy patient No smoking
Key exclusion criteria (1 listed)
- history of smoking Medical disease
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 |
|---|---|---|
| Normal salineSaline will be applied after surgery | Drug | Control |
| DexamethasoneDexamethason will be given IV before surgery | Drug | Dexamethason |
| HoneyHoney will be applied locally after surgery | Drug | Natural honey |
| Dexamethasone and honeyDexamethason will be given IV before surgery and then Honey will be applied locally after surgery | Drug | Dexamethason and natural honey |
Primary outcome
Interincisal distance
Time frame: Preoperative
Distance between upper and lower teeth will be measured in mm by ruler
Interincisal distance
Time frame: I day postoperative
Distance between upper and lower teeth will be measured in mm by ruler
Interincisal distance
Time frame: 3rd day postoperative
Distance between upper and lower teeth will be measured in mm by ruler
Interincisal distance
Time frame: 7th day postoperative
Distance between upper and lower teeth will be measured in mm by ruler
Edema
Time frame: Preoperative
Measured from angle of mandible to angle of mouth
Edema
Time frame: 1day postoperative
Measured from angle of mandible to angle of mouth
Edema
Time frame: 2nd day postoperative
Measured from angle of mandible to angle of mouth in mm by ruler
Edema
Time frame: 3rd day postoperative
Measured from angle of mandible to angle hof mouth in mm by ruler
Edema
Time frame: 7th day postoperative
Measured from angle of mandible to angle of mouth in mm by ruler
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 22 Jul 2021.
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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 Early Phase 1 study testing Normal saline, Dexamethasone and Honey in people with Impacted Third Molar Tooth, run by Al-Azhar University at 1 site in Saudi Arabia.
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 2 inclusion and 1 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 22 Jul 2021. 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 Saudi Arabia. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Interincisal distance (time frame: Preoperative). The study lists 9 primary outcomes in all. 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 22 Jul 2021.