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

NCT07072182 — Not applicable, Completed, 40 participants, Fatma saad saad mahmoud elsherbini

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Evaluation of the Effect of Different Biomaterials on Palatal Wound Healing. A Randomized Controlled Clinical Study

Registry	NCT07072182
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	40 (Actual)
Sponsor	Fatma saad saad mahmoud elsherbini (Other)
Conditions	Heal Wound, VAS Will be Used to Assess Pain Postoperative
Interventions	Palatal wound will be covered with Ora-aid patch, Palatal wound will be covered with Composite stent, Palatal wound will be covered with PRF (Device, combination product)
Dates	start 2025-03-20, primary completion 2025-05-20, completion 2025-06-20, first posted 2025-07-18, last updated 2025-07-18
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
control group	No intervention		Palatal wound will be left to heal spontaneously
study group 1	Experimental	Device: Palatal wound will be covered with Composite stent	Palatal wound will be covered with Composite stent
study group 2	Experimental	Combination Product: Palatal wound will be covered with PRF	Palatal wound will be covered with PRF
study group 3	Experimental	Device: Palatal wound will be covered with Ora-aid patch	Palatal wound will be covered with Ora-aid patch

Palatal wound will be covered with Ora-aid patch (Device), also known as ora aid: Palatal wound will be covered with Ora-aid patch
Palatal wound will be covered with Composite stent (Device): Palatal wound will be covered with Composite stent
Palatal wound will be covered with PRF (Combination product), also known as prf: Palatal wound will be covered with PRF

+Outcome measures

Primary outcomes

Wound healing assessment [From enrollment to the end of treatment at 4 weeks]: 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.
Pain using the visual analogue scale [From enrollment to the end of treatment at 4 weeks]: 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

Secondary outcomes

Patient satisfaction through direct communication [From enrollment to the end of treatment at 4 weeks]: 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

+Eligibility

Sex: All, ages: 20 Years to 40 Years

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.

+Locations (1)

Facility	City	Country	Status
Mansoura university Faculty of dentistry	Al Mansurah, Dakhlia	Egypt