ClinicalTrials.gg
Status unknownNCT03402321Updated Feb 8, 2019

Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting

A Phase 4 interventional study of Gelatin Sponge Sheet and Alvogyl in Pain, Procedural, sponsored by Karim ehab gerges. Status unknown. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Karim ehab gerges · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Randomized
Sex
All
01

Study summary

clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.

02

Conditions studied

  • Pain, Procedural

Keywords

  • alveogyl, gelatin sponge, free gingival graft, palate, pain
03

In context

Pain, Procedural

241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

This study's planned enrollment of 36 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.

Browse Pain, Procedural studies →

Lead sponsor

This is the only study on the registry with Karim ehab gerges as lead sponsor.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
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

  1. Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting
  2. Systemically healthy

Exclusion criteria

Exclusion Criteria:

  1. Severe gagging reflex
  2. Smokers
  3. Occlusal trauma at site of graft
  4. Pregnancy
  5. Psychiatric disorder
  6. Patients allergic to the used agents
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    control group

    Gelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site

    Drug: Gelatin Sponge Sheet

  • Experimental
    intervention group

    alvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain

    Drug: Alvogyl

Interventions

  • DrugGelatin Sponge Sheet

    sheets act as a mechanical barrier used to protect the denuded area of the palatal donor site

    Also known as: gel foam

  • paste form with analgesic action to protect the palatal donor site and help to relief pain

    Also known as: Alveogyl

06

What researchers measure

Primary outcomes

  1. pain score

    recorded by the pain trough a Visual Analogue scale score (between 0 and 10. 0: no pain, 1: minimal pain,10: severe pain)

    Time frame: 2 weeks

Secondary outcomes

  1. healing

    healing of the palatal mucosa using H2O2 Test this test is based on the principle that if the epithelium is discontinuous, then H2O2 diffuses into the CT, the enzyme catalase acts on H2O2to release water and oxygen. This is shown clinically by the production of bubbles on the wound. The area to be evaluated is then dried, and 3% H2O2 is sprinkled on the wound with a syringe, waiting for the appearance of bubbles, which will suggest that the surgical site is not completely epithelialized. Complete healing will be recorded as a dichotomous variable (yes/no).

    Time frame: 4 weeks

  2. bleeding

    Questionaire, Binary (yes or no).

    Time frame: 2 weeks

  3. analgesic consumption

    questionaure, Numerical, Amount of analgesics daily consumption

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ehab K, Abouldahab O, Hassan A, Fawzy El-Sayed KM. Alvogyl and absorbable gelatin sponge as palatal wound dressings following epithelialized free gingival graft harvest: a randomized clinical trial. Clin Oral Investig. 2020 Apr;24(4):1517-1525. doi: 10.1007/s00784-020-03254-z. Epub 2020 Mar 6. PubMed 32144515 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2019; primary completion for Jun 2019, 2 months later.

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

Registered
Dec 27, 2017
First posted
Jan 18, 2018
StartEst.
Apr 1, 2019
Primary completionEst.
Jun 1, 2019
CompletionEst.
Jul 1, 2019
Last update
Feb 8, 2019
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 Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03402321
Lead sponsor
Karim ehab gerges
Responsible party
Karim ehab gerges (Principal Investigator, Cairo University) — Sponsor-investigator
First posted
Jan 18, 2018
Start date
Apr 1, 2019 (estimated)
Primary completion
Jun 1, 2019 (estimated)
Completion
Jul 1, 2019 (estimated)
Last update
Feb 8, 2019

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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