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

NCT07072182 | Completed

• 1 other identifier: M0101025OM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heal Wound; VAS Will be Used to Assess Pain Postoperative

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the end of treatment at 4 weeks

• 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

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Patient satisfaction through direct communication

  From enrollment to the end of treatment at 4 weeks

Study Arms (4)

control group

NO INTERVENTION

Palatal wound will be left to heal spontaneously

study group 1

EXPERIMENTAL

Palatal wound will be covered with Composite stent

Device: Palatal wound will be covered with Composite stent

study group 2

EXPERIMENTAL

Palatal wound will be covered with PRF

Combination Product: Palatal wound will be covered with PRF

study group 3

EXPERIMENTAL

Palatal wound will be covered with Ora-aid patch

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

Interventions

Palatal wound will be covered with Ora-aid patch DEVICE

Palatal wound will be covered with Ora-aid patch

Also known as: ora aid

study group 3

Palatal wound will be covered with Composite stent DEVICE

Palatal wound will be covered with Composite stent

study group 1

Palatal wound will be covered with PRF COMBINATION_PRODUCT

Palatal wound will be covered with PRF

Also known as: prf

study group 2

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating females,
• Patients with untreated periodontal condition and
• Patients with uncontrolled systemic condition.

Sponsors & Collaborators

• Fatma saad saad mahmoud elsherbini: lead

Study Sites (1)

Mansoura university Faculty of dentistry

Al Mansurah, Dakhlia, 35516, Egypt

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Lecturer, Oral Medicine, Periodontology, Diagnosis, and Oral Radiology Department,

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 18, 2025
• Study Start: March 20, 2025
• Primary Completion: May 20, 2025
• Study Completion: June 20, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)