Wound HealNCT05850819
Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial
A study testing Colloidal silver gelatin sponge and Sterile gauze pack in people with Wound Heal, run by Melaka Manipal Medical College at 1 site in Malaysia.
Trial summary
This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Colloidal silver gelatin sponge and Sterile gauze pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2022to 30 Mar 2023
- 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 requiring extraction of mandibular teeth
- Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II)
- Patients not allergic to the drugs or anesthetics used in the study.
Who cannot join
- Patients taking medications that influences wound healing
- smokers
- Uncooperative patients
- Patients requiring extraction of grade II or III mobile teeth
- Patients requiring surgical extraction of teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Gelatamp in Wound Healing After Extraction of Teeth: A Randomized Clinical Trial
This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.
Read the detailed description
In the interventional group, after extraction of mandibular teeth, the extraction socket will be augmented with Gelatamp. Then a gauze pack will be placed over it.
In the control group, after extraction of mandibular teeth, a gauze pack will be placed over the socket.
- Conditions
- Wound Heal
- Being tested
- Colloidal silver gelatin sponge, Sterile gauze pack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colloidal silver gelatin spongeDrug
Also called Gelatamp
Augment the extraction socket with Gelatamp
Sterile gauze packDrug
Extraction socket allowed to heal without augmentation with any material
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Application of Gelatamp in the extraction socket Receives: Drug: Colloidal silver gelatin sponge |
| Group B | Active comparator | Extraction socket allowed to heal without application of Gelatamp Receives: Drug: Sterile gauze pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative wound healing
A 5 point early wound healing scale assessing wound healing after 7 postoperative days
Measured: 7th postoperative day
Postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Measured: 1st postoperative day
Postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Measured: 2nd postoperative day
postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Measured: 3rd postoperative day
postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Measured: 4th postoperative day
postoperative pain
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Measured: 5th postoperative day
Secondary outcomes (1)
Presence of dry socket
presence of pain, foul odour, exposed bone in the extraction socket
Measured: 3rd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jul 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melaka Manipal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Kalam Azad, Melaka Manipal Medical College
- Investigators
- Abdul K Azad, Principal investigator, Melaka Manipal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850819
- Sponsor's protocol ID
- MUCM/FOD/AR/B10/E C-2022(03)
- Status last verified
- May 2023
- First submitted
- 29 Apr 2023
- Last updated
- 11 May 2023
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gelatamp in Wound Healing After Extraction of Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05850819
- Acronym / sponsor ID
- MUCM/FOD/AR/B10/E C-2022(03)
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Melaka Manipal Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 9 May 2023 (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 compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.
Detailed description
In the interventional group, after extraction of mandibular teeth, the extraction socket will be augmented with Gelatamp. Then a gauze pack will be placed over it.
In the control group, after extraction of mandibular teeth, a gauze pack will be placed over the socket.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Colloidal silver gelatin spongeApplication of Gelatamp in the extraction socket |
| Group B | Active comparator | Drug: Sterile gauze packExtraction socket allowed to heal without application of Gelatamp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring extraction of mandibular teeth
- Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II)
- Patients not allergic to the drugs or anesthetics used in the study.
Key exclusion criteria (5 listed)
- Patients taking medications that influences wound healing
- smokers
- Uncooperative patients
- Patients requiring extraction of grade II or III mobile teeth
- Patients requiring surgical extraction of teeth.
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 |
|---|---|---|
| Colloidal silver gelatin spongeAlso: GelatampAugment the extraction socket with Gelatamp | Drug | Group A |
| Sterile gauze packExtraction socket allowed to heal without augmentation with any material | Drug | Group B |
Primary outcome
Postoperative wound healing
Time frame: 7th postoperative day
A 5 point early wound healing scale assessing wound healing after 7 postoperative days
Postoperative pain
Time frame: 1st postoperative day
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
Postoperative pain
Time frame: 2nd postoperative day
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
postoperative pain
Time frame: 3rd postoperative day
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
postoperative pain
Time frame: 4th postoperative day
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
postoperative pain
Time frame: 5th postoperative day
A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).
1 secondary outcome
Presence of dry socket
Time frame: 3rd postoperative day
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 11 May 2023.
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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.
Abdul K Azad principal investigator
Melaka Manipal Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colloidal silver gelatin sponge and Sterile gauze pack in people with Wound Heal, run by Melaka Manipal Medical College at 1 site in Malaysia.
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 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 11 May 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 Malaysia. 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?
Postoperative wound healing (time frame: 7th postoperative day). The study lists 6 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 11 May 2023.