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

Fatma saad saad mahmoud elsherbini

Status: Completed

Conditions: Heal Wound; VAS Will be Used to Assess Pain Postoperative

Treatments: Combination Product: Palatal wound will be covered with PRF; Device: Palatal wound will be covered with Composite stent; Device: Palatal wound will be covered with Ora-aid patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07072182

M0101025OM

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 4 patient groups

control group

No Intervention group

Description:

Palatal wound will be left to heal spontaneously

study group 1

Experimental group

Description:

Palatal wound will be covered with Composite stent

Treatment:

Device: Palatal wound will be covered with Composite stent

study group 2

Experimental group

Description:

Palatal wound will be covered with PRF

Treatment:

Combination Product: Palatal wound will be covered with PRF

study group 3

Experimental group

Description:

Palatal wound will be covered with Ora-aid patch

Treatment:

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