ClinicalTrials.gg
CompletedNCT05850819Updated May 11, 2023

Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial

An interventional study of Colloidal silver gelatin sponge and Sterile gauze pack in Wound Heal, sponsored by Melaka Manipal Medical College. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Melaka Manipal Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2022, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Wound Heal
03

In context

Lead sponsor

Melaka Manipal Medical College is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients requiring extraction of mandibular teeth
  • Healthy patients () or patients with mild systemic disease but no functional limitations (ASA II)
  • Patients not allergic to the drugs or anesthetics used in the study.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Group A

    Application of Gelatamp in the extraction socket

    Drug: Colloidal silver gelatin sponge

  • Active comparator
    Group B

    Extraction socket allowed to heal without application of Gelatamp

    Drug: Sterile gauze pack

Interventions

  • DrugColloidal silver gelatin sponge

    Augment the extraction socket with Gelatamp

    Also known as: Gelatamp

  • DrugSterile gauze pack

    Extraction socket allowed to heal without augmentation with any material

06

What researchers measure

Primary outcomes

  1. Postoperative wound healing

    A 5 point early wound healing scale assessing wound healing after 7 postoperative days

    Time frame: 7th postoperative day

  2. Postoperative pain

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

    Time frame: 1st postoperative day

  3. Postoperative pain

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

    Time frame: 2nd postoperative day

  4. postoperative pain

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

    Time frame: 3rd postoperative day

  5. postoperative pain

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

    Time frame: 4th postoperative day

  6. postoperative pain

    A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

    Time frame: 5th postoperative day

Secondary outcomes

  1. Presence of dry socket

    presence of pain, foul odour, exposed bone in the extraction socket

    Time frame: 3rd postoperative day

07

Study locations

1 site
  • Melaka Manipal Medical College
    Melaka, 75150, Malaysia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Mar 2023, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2023
First posted
May 9, 2023
StartActual
Jul 1, 2022
Primary completionActual
Mar 30, 2023
CompletionActual
Mar 30, 2023
Last update
May 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05850819
Lead sponsor
Melaka Manipal Medical College
Responsible party
Abdul Kalam Azad (Assistant Professor, Melaka Manipal Medical College) — Principal investigator
First posted
May 9, 2023
Start date
Jul 1, 2022
Primary completion
Mar 30, 2023
Completion
Mar 30, 2023
Last update
May 11, 2023

Study contacts

Abdul K Azad
principal investigator · Melaka Manipal Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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