Impacted Third Molar ToothPhase 3NCT04424875
The Effect of Melatonin Application Following Removal of Impacted Third Molar
A Phase 3 study testing 3 mg melatonin in people with Impacted Third Molar Tooth, run by Fayoum University at 1 site in Egypt.
Trial summary
In the present study, the main hypothesis hypothesizes that the local application of melatonin in the post-extraction socket produces favorable differences in the immediate postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the natural healing process of the socket. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- 3 mg melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 May 2021
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18ys
- no systemic disease
- impacted mandibular third molar class II position B on Pell- Gregory classification
Who cannot join
- history of metabolic or systemic diseases affecting bone or healing process,
- local infection,
- tobacco use,
- oral contraceptive,
- pregnancy and lactation
- patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Melatonin Application Following Removal of an Impacted Mandibular Third Molar: A Randomized Controlled Clinical Trial
In the present study, the main hypothesis hypothesizes that the local application of melatonin in the post-extraction socket produces favorable differences in the immediate postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the natural healing process of the socket.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- 3 mg melatonin, Placebo
- Keywords
- impacted third molar, melatonine, bone healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mg melatoninDrug
Also called melatonin group
patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%
PlaceboDrug
Also called cellulose group
patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | patients will undergo surgery to remove impacted lower third molar and receive Melatonin (3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%) in the socket following removal of the impacted third molar Receives: Drug: 3 mg melatonin |
| controlled arm | Placebo comparator | patients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
The bone density within the extraction socket was measured using software of cone beam
Measured: 6months
Secondary outcomes (4)
Osteoprotegerin (OPG)
Human Osteoprotegerin (OPG) ELISA Kit was used to detect OPG levels.The changes in OPG in the whole group in the predetermined period immediate postoperative , after 4 week,and 6months
Measured: 4weeks postoperatively
pain sensation
a visual analogue scale (VAS) of 10 units in combination with a graphic rating scale. On the VAS, the left most end represented the absence of pain (score 0) and the right most end indicated the most severe pain (score 10).
Measured: 7 days postoperative
swelling
a tape measure, from the tragus to the corner of the mouth.
Measured: 7 days postoperative
trismus
measuring the distance between incisal edges of upper and lower central incisor at maximal mouth
Measured: 7days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424875
- Sponsor's protocol ID
- Melatonin and 3rd molar
- Status last verified
- May 2021
- First submitted
- 7 Jun 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cobo-Vazquez C, Fernandez-Tresguerres I, Ortega-Aranegui R, Lopez-Quiles J. Effects of local melatonin application on post-extraction sockets after third molar surgery. A pilot study. Med Oral Patol Oral Cir Bucal. 2014 Nov 1;19(6):e628-33. doi: 10.4317/medoral.19851.
PubMed 25350595
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Melatonin Application Following Removal of an Impacted Mandibular Third Molar: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04424875
- Acronym / sponsor ID
- Melatonin and 3rd molar
- Conditions
- Impacted Third Molar Tooth
- Keywords
- impacted third molar, melatonine, bone healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 11 Jun 2020 (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.
In the present study, the main hypothesis hypothesizes that the local application of melatonin in the post-extraction socket produces favorable differences in the immediate postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the natural healing process of the socket.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Drug: 3 mg melatoninpatients will undergo surgery to remove impacted lower third molar and receive Melatonin (3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%) in the socket following removal of the impacted third molar |
| controlled arm | Placebo comparator | Drug: Placebopatients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18ys
- no systemic disease
- impacted mandibular third molar class II position B on Pell- Gregory classification
Key exclusion criteria (6 listed)
- history of metabolic or systemic diseases affecting bone or healing process,
- local infection,
- tobacco use,
- oral contraceptive,
- pregnancy and lactation
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 |
|---|---|---|
| 3 mg melatoninAlso: melatonin grouppatients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2% | Drug | study arm |
| PlaceboAlso: cellulose grouppatients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2% | Drug | controlled arm |
Primary outcome
Bone density
Time frame: 6months
The bone density within the extraction socket was measured using software of cone beam
4 secondary outcomes
Osteoprotegerin (OPG)
Time frame: 4weeks postoperatively
pain sensation
Time frame: 7 days postoperative
swelling
Time frame: 7 days postoperative
trismus
Time frame: 7days postoperative
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 18 May 2021.
- Background: PubMed 25350595Cobo-Vazquez C, Fernandez-Tresguerres I, Ortega-Aranegui R, Lopez-Quiles J. Effects of local melatonin application on post-extraction sockets after third molar surgery. A pilot study. Med Oral Patol Oral Cir Bucal. 2014 Nov 1;19(6):e628-33. doi: 10.4317/medoral.19851.
- Individual participant dataSharing planned: No
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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 Phase 3 study testing 3 mg melatonin in people with Impacted Third Molar Tooth, run by Fayoum University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 18 May 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 Egypt. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Bone density (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424875, which also lists 1 linked publication.
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 18 May 2021.