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Completed

NCT Number: NCT07072182

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

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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Key information

Conditions

Heal Wound VAS Will be Used to Assess Pain Postoperative

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university Faculty of dentistry

Al Mansurah, Dakhlia, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palatal wound will be covered with Ora-aid patch

Device

Palatal wound will be covered with Ora-aid patch

Other names: ora aid

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

Palatal wound will be covered with PRF

Other names: prf

Primary outcomes

  1. Wound healing assessment

    Time frame: 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.

  2. Pain using the visual analogue scale

    Time frame: 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

  1. Patient satisfaction through direct communication

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fatma saad saad mahmoud elsherbini

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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