Post Operative SwellingGelatin SpongeNCT07306403
THE COMPARISON OF GELATIN SPONGE TO SUTURE ALONE ON POST OPERATIVE SWELLING AFTER EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR.
A study testing Gelatin Sponge Sheet and Swelling in people with Post Operative Swelling and Impacted Mandibular Third Molar Extraction, run by Watim Medical & Dental College at 1 site in Pakistan.
Trial summary
This Study is designed for purpose to increase patient safety and reduce complications which occurs after mandibular 3rd molar extraction which is will increase discomfort after extraction. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Swelling, Impacted Mandibular Third Molar Extraction
- What is being tested?
- Gelatin Sponge Sheet and Swelling
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2024to 30 Mar 2025
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30 years old.
- Either gender.
- impacted third mandibular molar.
- No history of periodontists
- No bone recession on radiograph
- Swelling at the side of impaction.
Who cannot join
- Patients with ASA status lll and above.
- -Patients requiring multiple extractions in same appointment.
- Patients allergic to Lignocaine.
- Patients in whom adrenaline is contraindicated.
- Medically compromised individual such as those with poorly controlled diabetes, hypertension and pregnancy,
Trial locations and contacts
1 site in 1 country.
About this study
This Study is designed for purpose to increase patient safety and reduce complications which occurs after mandibular 3rd molar extraction which is will increase discomfort after extraction. My study hypothesis is that gelatin sponge after extraction reduce swelling post extraction wisdom tooth.For understanding when we remove wisdom tooth, we involve hard and soft tissiues which will result in post extraction swelling.
- Being tested
- Gelatin Sponge Sheet, Swelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin Sponge SheetDevice
Also called Sponge Stone, Suture
Gelatin sponge vs Suture Alone
SwellingProcedure or surgery
Suture
| Study group | Role | What they receive |
|---|---|---|
| Gelatin Sponge | Other | Swelling Receives: Device: Gelatin Sponge Sheet; Procedure: Swelling |
| Suture Alone | Other | Swelling Receives: Device: Gelatin Sponge Sheet; Procedure: Swelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Extraction Swelling
Measurements will be taken from angle of mandible to commissure of lips by measuring tape by Amin and Laskin Method.
Measured: Pre extraction, 1st day post extraction, 3rd day post extraction and 7th day post extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Aug 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative SwellingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Mohammad Irfan, Watim Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306403
- Sponsor's protocol ID
- Ethical Review Board
- Acronym
- Gelatin Sponge
- Status last verified
- Aug 2024
- First submitted
- 28 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Because want to avoid sharing their identity
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE COMPARISON OF GELATIN SPONGE TO SUTURE ALONE ON POST OPERATIVE SWELLING AFTER EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR.
- ClinicalTrials.gov ID
- NCT07306403
- Acronym / sponsor ID
- Gelatin Sponge / Ethical Review Board
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 29 Dec 2025 (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 Study is designed for purpose to increase patient safety and reduce complications which occurs after mandibular 3rd molar extraction which is will increase discomfort after extraction. My study hypothesis is that gelatin sponge after extraction reduce swelling post extraction wisdom tooth.For understanding when we remove wisdom tooth, we involve hard and soft tissiues which will result in post extraction swelling.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelatin Sponge | Other | Device: Gelatin Sponge Sheet, Procedure: SwellingSwelling |
| Suture Alone | Other | Device: Gelatin Sponge Sheet, Procedure: SwellingSwelling |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-30 years old.
- Either gender.
- impacted third mandibular molar.
- No history of periodontists
- No bone recession on radiograph
Key exclusion criteria (5 listed)
- Patients with ASA status lll and above.
- -Patients requiring multiple extractions in same appointment.
- Patients allergic to Lignocaine.
- Patients in whom adrenaline is contraindicated.
- Medically compromised individual such as those with poorly controlled diabetes, hypertension and pregnancy,
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 |
|---|---|---|
| Gelatin Sponge SheetAlso: Sponge Stone, SutureGelatin sponge vs Suture Alone | Device | Gelatin Sponge, Suture Alone |
| SwellingSuture | Procedure or surgery | Gelatin Sponge, Suture Alone |
Primary outcome
Post Extraction Swelling
Time frame: Pre extraction, 1st day post extraction, 3rd day post extraction and 7th day post extraction.
Measurements will be taken from angle of mandible to commissure of lips by measuring tape by Amin and Laskin Method.
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 29 Dec 2025.
- Individual participant dataSharing planned: No. Because want to avoid sharing their identity
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Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy
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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 Gelatin Sponge Sheet and Swelling in people with Post Operative Swelling and Impacted Mandibular Third Molar Extraction, run by Watim Medical & Dental College at 1 site in Pakistan.
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 6 inclusion and 5 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 29 Dec 2025. 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 Pakistan. 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?
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?
Post Extraction Swelling (time frame: Pre extraction, 1st day post extraction, 3rd day post extraction and 7th day 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 29 Dec 2025.