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CompletedNCT07072182Updated Jul 18, 2025

Evaluation of the Effect of Different Biomaterials on Palatal Wound Healing.

An interventional study of Palatal wound will be covered with Ora-aid patch and Palatal wound will be covered with Composite stent in Heal Wound and VAS Will be Used to Assess Pain Postoperative, sponsored by Fatma saad saad mahmoud elsherbini. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by Fatma saad saad mahmoud elsherbini · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2025, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study summary

All study subjects will sign written informal consent form before enrolment.

They will be divided into four groups, 10 patients each:

  • Group I: Palatal wound will be left to heal spontaneously,
  • Group II: Palatal wound will be covered with Composite stent,
  • Group III: Palatal wound will be covered with PRF,
  • Group IV: Palatal wound will be covered with Ora-aid patch. III- Surgical Procedures: -
  • After harvesting the palatal soft tissue graft with the standardized dimensions (12 × 7 mm) of the graft for all patients. Graft thickness was standardized as well to be approximately 1.5 to 2 mm and confirmed with a caliper at 3 points (ends and centre of the graft). Fixing of the graft at the recipient site will be performed, back to the donor site for management, the blood clot will be wiped with gauze, then placement of different materials according to each group.
  • The dressing will be then pressed gently for 10 seconds, to aid its adherence to the wound. Fixation of the patch will be followed, using 5/0 propylene suture, with performing sling horizontal figure eight suture technique.
02

Conditions studied

  • Heal Wound
  • VAS Will be Used to Assess Pain Postoperative
03

In context

Lead sponsor

This is the only study on the registry with Fatma saad saad mahmoud elsherbini as lead sponsor.

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

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:-

  • Patients who are indicated for soft tissue augmentation procedures, either with root coverage or to increase the deficient keratinized tissue,
  • Medically free patients,
  • Non-smokers and
  • Patients with good oral hygiene. Exclusion Criteria:-
  • Pregnant or lactating females,
  • Patients with untreated periodontal condition and
  • Patients with uncontrolled systemic condition.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    control group

    Palatal wound will be left to heal spontaneously

  • Experimental
    study group 1

    Palatal wound will be covered with Composite stent

    Device: Palatal wound will be covered with Composite stent

  • Experimental
    study group 2

    Palatal wound will be covered with PRF

    Combination Product: Palatal wound will be covered with PRF

  • Experimental
    study group 3

    Palatal wound will be covered with Ora-aid patch

    Device: Palatal wound will be covered with Ora-aid patch

Interventions

  • DevicePalatal wound will be covered with Ora-aid patch

    Palatal wound will be covered with Ora-aid patch

    Also known as: ora aid

  • DevicePalatal wound will be covered with Composite stent

    Palatal wound will be covered with Composite stent

  • Combination productPalatal wound will be covered with PRF

    Palatal wound will be covered with PRF

    Also known as: prf

06

What researchers measure

Primary outcomes

  1. Wound healing assessment

    The parameters of tissue color, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration were evaluated as this index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing gets a score of 5.

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. Pain using the visual analogue scale

    Patients were asked about their pain levels, swelling, and other experiences related to the surgical techniques and instruments to assess postoperative pain. The perceived discomfort was rated using a VAS, which is marked at two endpoints: "no discomfort" at one end (score of 0) and "unbearable discomfort" at the other end (score of 10). Patients completed the questionnaires on the 1st, 2nd, 4th, 7th, and 14th days after their surgery

    Time frame: From enrollment to the end of treatment at 4 weeks

Secondary outcomes

  1. Patient satisfaction through direct communication

    Patient satisfaction (PS) was evaluated using a three-point rating scale: 3 for fully satisfied, 2 for satisfied, and 1 for unsatisfied. Each patient was asked about their satisfaction with the following patient-centered criteria: root coverage achieved, relief from dentinal hypersensitivity, color of the gingiva, shape and contour of the gingiva, surgical procedure (including pain during surgery and discomfort related to the duration of the procedure and the operator's handling), post-surgical phase (including pain, swelling, and any postoperative complications), and cost-effectiveness (patients were asked if they felt the treatment justified the time and money spent). This approach aimed to gather comprehensive feedback on the overall patient experience

    Time frame: From enrollment to the end of treatment at 4 weeks

07

Study locations

1 site
  • Mansoura university Faculty of dentistry
    Al Mansurah, Dakhlia 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07072182
Lead sponsor
Fatma saad saad mahmoud elsherbini
Responsible party
Fatma saad saad mahmoud elsherbini (PhD, Lecturer, Oral Medicine, Periodontology, Diagnosis, and Oral Radiology Department,, Mansoura University) — Sponsor-investigator
First posted
Jul 18, 2025
Start date
Mar 20, 2025
Primary completion
May 20, 2025
Completion
Jun 20, 2025
Last update
Jul 18, 2025

Oversight

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

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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