Impacted Third Molar ToothGum Health gelNCT06251141
Gum Health Gel in Post Extraction Sockets
A study testing Gum Health gel and Gel foam in people with Impacted Third Molar Tooth, run by University of Baghdad at 1 site in Iraq.
Trial summary
This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars 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
- What is being tested?
- Gum Health gel and Gel foam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIraq
- Study dates
- 15 Feb 2024to 19 Sep 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
Inclusion Criteria: Horizontal and mesioangular impaction in healthy patients older than 18 years old -
Exclusion Criteria:any medically compromised patient and the presence of any infection
-
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Collage of dentistry/ university of baghdad
Baghdad
Collage Of Dentistry, http://..........@codental.uobaghdad.edu.iq
About this study
Official title: Effectiveness of Gum Health Gel in Minimizing Post Operative Sequelae Associated With the Surgical Removal of Impacted Mandibular Third Molars
This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars
Read the detailed description
This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars which includes pain , swelling and trismus
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Gum Health gel, Gel foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum Health gelProcedure or surgery
Extraction of impacted mandibular third molars under local anaesthesia and irrigating the socket with normal saline, and filling the socket with the Gum Health gel
Gel foamProcedure or surgery
Extraction of impacted mandibular third molars under local anaesthesia and irrigating the socket
| Study group | Role | What they receive |
|---|---|---|
| Study group gum Health gel | Active comparator | Study group we fill the sockets with gel foam immersed with Gum Health gel Receives: Procedure: Gum Health gel |
| Control group gel foam | Placebo comparator | Control group we fill the sockets with gel foam only Receives: Procedure: Gel foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of Pain
Pain with Visual analog scale
Measured: One week
Increase Soft tissue healing
Soft tissue healing with Early wound healing scale
Measured: One week
Decrease in Trismus
Trismus with Maximum-interincisal- opening (MIO) thatimillimeters
Measured: One week
Decrease of Swelling
Swelling withGrades of swelling
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Feb 2024
- Primary completion19 Aug 2024 (estimated)
- Study completion19 Sep 2024 (estimated)
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 University of BaghdadThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhuha Ali Bardan, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251141
- Sponsor's protocol ID
- 894124
- Acronym
- Gum Health gel
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gum Health Gel in Minimizing Post Operative Sequelae Associated With the Surgical Removal of Impacted Mandibular Third Molars
- ClinicalTrials.gov ID
- NCT06251141
- Acronym / sponsor ID
- Gum Health gel / 894124
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 19 Aug 2024 (estimated)
- Study completion
- 19 Sep 2024 (estimated)
- First posted
- 9 Feb 2024 (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.
This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars
Detailed description
This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars which includes pain , swelling and trismus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group gum Health gel | Active comparator | Procedure: Gum Health gelStudy group we fill the sockets with gel foam immersed with Gum Health gel |
| Control group gel foam | Placebo comparator | Procedure: Gel foamControl group we fill the sockets with gel foam only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Gum Health gelExtraction of impacted mandibular third molars under local anaesthesia and irrigating the socket with normal saline, and filling the socket with the Gum Health gel | Procedure or surgery | Study group gum Health gel |
| Gel foamExtraction of impacted mandibular third molars under local anaesthesia and irrigating the socket | Procedure or surgery | Control group gel foam |
Primary outcome
Decrease of Pain
Time frame: One week
Pain with Visual analog scale
Increase Soft tissue healing
Time frame: One week
Soft tissue healing with Early wound healing scale
Decrease in Trismus
Time frame: One week
Trismus with Maximum-interincisal- opening (MIO) thatimillimeters
Decrease of Swelling
Time frame: One week
Swelling withGrades of swelling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum Health gel and Gel foam in people with Impacted Third Molar Tooth, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. 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 Iraq. 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.
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?
Contact Ahmed F, Quisi (+9647811896313, Ahmedquisi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of Pain (time frame: One week). The study lists 4 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 16 Feb 2024.